| EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K030944) | Edwards Lifesciences, LLC | 2003-06-20 |
| MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 (K031583) | Integrated Vascular Systems, Inc. | 2003-06-16 |
| COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM (K023937) | Cook Vascular, Inc. | 2003-05-27 |
| EDWARDS INTRODUCER SHEATH (K031087) | Edwards Lifesciences, LLC | 2003-04-24 |
| MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (K030905) | Medamicus, Inc. | 2003-04-09 |
| IVS INTRODUCER SET, MODEL 1003 (K030723) | Integrated Vascular Systems, Inc. | 2003-04-03 |
| INNER-LOCK LOCKING INTRODUCER SHEATHS (K022170) | Rex Medical | 2003-01-21 |
| CO-AXIAL INTRODUCER NEEDLE (K022634) | Promex, Inc. | 2002-11-06 |
| MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) (K023447) | St Jude Medical | 2002-10-31 |
| MEDCOMP VASCU-SHEATH INTRODUCER SET (K022513) | Medcomp | 2002-10-25 |
| NEICH NM ADVANCE CATHETER SHEATH INTRODUCER (K020964) | Neich Medical(Shenzhen)Company, Ltd. | 2002-10-11 |
| TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 (K022003) | Micro Therapeutics, Inc. | 2002-09-13 |
| MODIFICATION TO MEDAMICUS AXIA RSN (K022689) | Medamicus, Inc. | 2002-08-23 |
| SHEATH ADAPTER, MODEL SA-09847 (K021723) | Arrow Intl., Inc. | 2002-08-08 |
| INTROCAN SAFETY IV CATHETER (K021094) | B.Braun Medical, Inc. | 2002-07-03 |
| BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I (K020834) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-06-12 |
| VALVED PEELABLE INTRODUCER (K021004) | Medamicus, Inc. | 2002-06-06 |
| MEDAMICUS AXIA RSN (K020563) | Medamicus, Inc. | 2002-05-21 |
| COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE (K010128) | Cook Vascular, Inc. | 2002-04-25 |
| EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K014052) | Edwards Lifesciences, LLC | 2002-03-08 |
| MODIFICATION TO TRANSSEPTAL INTRODUCER SET (K020090) | Thomas Medical Products, Inc. | 2002-02-11 |
| ANCURE SHEATH MODEL # 40315, 40320, 40325 (K003889) | Guidant Cardiac and Vascular Surgery | 2002-01-24 |
| RENAL GUIDING SHEATH (K012854) | Terumo Medical Corp. | 2001-11-21 |
| CAROTID GUIDING SHEATH (K012812) | Terumo Medical Corp. | 2001-11-14 |
| MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT (K011761) | Arrow Intl., Inc. | 2001-10-31 |
| MODIFICATION TO BRAIDED GUIDING INTRODUCER (K013202) | Thomas Medical Products, Inc. | 2001-10-23 |
| SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 (K013029) | St Jude Medical | 2001-10-09 |
| VYGON SPLIT CANNULA INTRODUCER (K010913) | Vygon Corp. | 2001-09-28 |
| ULTRAFLEX EV HEMOSTASIS INTRODUCER (K012922) | St Jude Medical | 2001-09-25 |
| MICROCRUISER PLUS INTRODUCER SET (K011790) | Medical Device Technologies, Inc. | 2001-09-05 |
| MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 (K012489) | Appriva Medical, Inc. | 2001-08-30 |
| SPLITTABLE SHEATH INTRODUCER KIT (K004025) | Thomas Medical Products, Inc. | 2001-07-19 |
| GUIDEWIRE INTRODUCER SAFETY NEEDLE (K011085) | Medamicus, Inc. | 2001-07-09 |
| BRAIDED GUIDING INTRODUCER (K004026) | Thomas Medical Products, Inc. | 2001-07-09 |
| INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX (K002847) | Maxxim Medical | 2001-05-31 |
| EMBOL-X INTRODUCER, MODEL CF00200 (K002973) | Embol-X, Inc. | 2001-04-26 |
| SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE (K003731) | Thomas Medical Products, Inc. | 2001-04-10 |
| TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT (K002507) | Arrow Intl., Inc. | 2001-03-21 |
| X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 (K002054) | Appriva Medical, Inc. | 2001-02-16 |
| INTRODEUCE DOUBLE LUMEN INTRODUCER (K001985) | Cook, Inc. | 2001-01-25 |
| ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), (K003729) | St Jude Medical | 2001-01-03 |
| ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 (K000004) | Daig Corp. | 2000-11-29 |
| PINNACLE R/O II OR RADIFOCUS INTRODUCER II (K003424) | Terumo Medical Corp. | 2000-11-21 |
| ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER (K002676) | Guidant Cardiac and Vascular Surgery | 2000-10-30 |
| VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES (K001926) | Thoratec Laboratories Corp. | 2000-09-22 |
| DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET (K002365) | Datascope Corp. | 2000-08-25 |
| 6F & 7F INTRODUCING CATHETERS (MODIFICATION) (K001135) | Cordis Corp. | 2000-07-03 |
| TEARAWAY INTRODUCER SHEATH (K000313) | Xentek Medical, Inc. | 2000-06-16 |
| FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX (K001367) | St. Jude Medical, Inc. | 2000-05-31 |
| INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) (K992668) | Innerdyne, Inc. | 2000-05-26 |
| ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX (K001346) | St. Jude Medical, Inc. | 2000-05-24 |
| ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX (K994334) | Daig Corp. | 2000-05-15 |
| PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M (K001139) | Biosense Webster, Inc. | 2000-05-10 |
| PERCUTANEOUS INTRODUCER, MODEL 10383-XXX (K000824) | Medamicus, Inc. | 2000-04-13 |
| TFX MEDICAL INTRODUCER ASSEMBLY (K993191) | Tfx Medical, Inc. | 2000-03-24 |
| IN-LINE HEMOSTASIS VALVE (K990975) | Merit Medical Systems, Inc. | 2000-03-15 |
| TFX MEDICAL INTRODUCER KIT (K991647) | Tfx Medical Group | 2000-01-04 |
| INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE (K994252) | Boston Scientific Corp | 2000-01-04 |
| INTRODUCER SHEATH, VESSEL DILATOR (K992309) | Boston Scientific Corp | 1999-10-07 |
| EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR (K983940) | Adam Spence Corp. | 1999-07-15 |
| MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET (K990705) | Medamicus, Inc. | 1999-06-28 |
| EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF (K983039) | Schneider/Namic | 1999-05-07 |
| SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 (K984062) | Diag Corp. | 1999-03-24 |
| PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) (K984260) | Terumo Medical Corp. | 1999-01-26 |
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K984500) | Cordis Corp. | 1998-12-23 |
| BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB (K982797) | Luther Medical Products, Inc. | 1998-11-30 |
| BAXTER HEMOSTASIS VALVE INTRODUCERS (K981909) | Baxter Edwards | 1998-11-24 |
| MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K983023) | Cordis Corp. | 1998-10-01 |
| FAST-CATH INTRA-CARDIAC INTRODUCER (K982187) | Daig Corp. | 1998-09-16 |
| INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) (K980578) | Innerdyne, Inc. | 1998-09-11 |
| CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S (K982740) | Cordis Webster, Inc. | 1998-08-28 |
| LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM (K981782) | Arrow Intl., Inc. | 1998-08-12 |
| EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET (K980504) | Schneider/Namic | 1998-08-07 |
| FAST-CATH (TM) INTRA-CARDIAC INTRODUCER (K973840) | Daig Corp. | 1998-05-21 |
| ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET (K970229) | Arrow Intl., Inc. | 1998-02-13 |
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K974448) | Cordis Corp. | 1998-02-06 |
| DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER (K973007) | Datascope Corp. | 1997-11-06 |
| CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM (K970264) | Cordis Webster, Inc. | 1997-10-28 |
| INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (K972684) | Innerdyne, Inc. | 1997-10-10 |
| HEARTPORT INTRODUCER SHEATH (K972570) | Heartport, Inc. | 1997-10-01 |
| PERCUTANEOUS VENOUS INTRODUCER 10264 (K965167) | Medamicus, Inc. | 1997-07-25 |
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K971608) | Cordis Corp. | 1997-07-21 |
| FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (K964518) | Daig Corp. | 1997-05-14 |
| BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K964814) | Bipore, Inc. | 1997-05-07 |
| TRANSJUGULAR ACCESS SET (K964034) | AngioDynamics, Inc. | 1997-05-06 |
| EVS (K963886) | Applied Medical Resources | 1997-04-24 |
| GSI CANNULA WITH INTRODUCER (K970201) | General Surgical Innovations | 1997-04-21 |
| CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM (K962978) | Johnson & Johnson Medical, Inc. | 1997-01-07 |
| HEMODIALYSIS INTRODUCER SET (K961780) | Thomas Medical Products, Inc. | 1996-12-24 |
| CATH SEAL (K962180) | Universal Medical Instrument Corp. | 1996-11-07 |
| CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT (K962746) | Cordis Corp. | 1996-10-11 |
| BRAUN PERCUTANEOUS INTRODUCER SET (K961745) | B.Braun Medical, Inc. | 1996-09-17 |
| PERCUTANEOUS INTRODUCER SET (K961466) | Thomas Medical Products, Inc. | 1996-09-12 |
| INPUT TUOHY-BORST LOCKING DEVICE (K960445) | C.R. Bard, Inc. | 1996-08-12 |
| SPREADABLE SHEATH INTRODUCER SET (K960625) | Neostar Medical Technologies, Inc. | 1996-08-08 |
| INTROSTAT LEAD INTRODUCER (K960200) | Msi, Inc. | 1996-07-02 |
| PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET (K961513) | Ep Medsystems | 1996-05-13 |
| INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) (K961135) | C.R. Bard, Inc. | 1996-04-30 |
| BRAUN HEMOSTASIS INTRODUCERS (K960406) | B.Braun Medical, Inc. | 1996-04-12 |
| FIRST PICC INTRODUCER CATHETER (K954906) | Becton Dickinson Vascular Access, Inc. | 1996-04-08 |