| FlexCath Select Steerable Sheath (10 French) (K142684) | Medtronic Cryocath, LP | 2014-11-06 |
| EpiAccess System (K142245) | Epiep, Inc. | 2014-10-29 |
| PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER (K140543) | Merit Medical Systems, Inc. | 2014-10-16 |
| FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (K132592) | Cook, Inc. | 2014-10-09 |
| EDWARDS ESHEATH INTRODUCER SET (K141696) | Edwards Lifesciences | 2014-09-18 |
| CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) (K140338) | Creganna-Tactx Medical | 2014-08-27 |
| GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER (K140028) | Galt Medical Corp. | 2014-08-21 |
| MERIT SAFETY INTRODUCER NEEDLE (K140513) | Merit Medical Systems, Inc. | 2014-07-09 |
| INTRODUCER, MODEL ADELANTE MAGNUM (K140917) | Oscor, Inc. | 2014-07-09 |
| MICROPUNCTURE INTRODUCER SET (K133114) | Cook Incorporated | 2014-07-03 |
| VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA (K140641) | Boston Scientific Corporation | 2014-07-03 |
| AXERA 2 ACCESS SYSTEM (K140871) | Arstasis, Inc. | 2014-06-06 |
| AXERA RX ACCESS SYSTEM (K140287) | Arstasis, Inc. | 2014-05-16 |
| MEDTRONIC INPUT PS INTRODUCER (K132617) | Medtronic, Inc. | 2014-04-30 |
| FLIP INTRODUCER ACCESS KIT (K132789) | Vascular Solutions, Inc. | 2014-04-17 |
| DESTINO TWIST, STEERABLE GUIDING SHEATH (K140406) | Oscor, Inc. | 2014-04-17 |
| VADO STEERABLE SHEATH (K140420) | Kalila Medical, Inc. | 2014-04-01 |
| AXERA 2 ACCESS SYSTEM (K140201) | Arstasis, Inc. | 2014-03-28 |
| EMBOL-X INTRODUCER SHEATH (K140398) | Edwards Lifesciences, LLC | 2014-03-19 |
| ULTIMUM EV HEMOSTASIS INTRODUCER (K140327) | St Jude Medical | 2014-03-11 |
| CATHETER INTRODUCER SHEATH (K131627) | Edwards Lifesciences, LLC | 2014-03-06 |
| XCATH (K133296) | Alseal | 2014-02-14 |
| INTRODUCER SETS, MODEL ADELANTE RADIAL (K130633) | Oscor, Inc. | 2014-02-13 |
| HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH (K132720) | Merit Medical Systems, Inc. | 2014-02-12 |
| CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER (K140015) | Cardiosolutions, Inc. | 2014-02-05 |
| SHOOCIN INTRODUCER KIT (K123475) | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-02-03 |
| VALVED TEARAWAY INTRODUCER GENERATION II (K132498) | Medcomp (Medical Components, Inc.) | 2013-11-25 |
| V-STICK VASCULAR ACCESS SET (K130730) | Argon Medical | 2013-11-22 |
| MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING (K132030) | Medtronic, Inc. | 2013-09-27 |
| HEARTSPAN STEERABLE INTRODUCER KIT (K132164) | Merit Medical Systems, Inc. | 2013-09-17 |
| THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH (K131148) | Access Scientific, LLC | 2013-09-04 |
| AXERA 2 ACCESS SYSTEM (K132263) | Arstasis, Inc. | 2013-08-19 |
| AMECO SHEATH INTRODUCER (K131144) | Ameco Medical Industries | 2013-08-15 |
| 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (K130687) | Medical Components, Inc. | 2013-08-15 |
| CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC (K131079) | Creganna Medical Devices | 2013-08-01 |
| PTFE SUPER SHEATH INTRODUCER (K130855) | Martech Medical Products | 2013-07-29 |
| EDWARDS EMBOL-X INTRODUCER SHEATH (K123714) | Edwards Lifesciences, LLC | 2013-07-24 |
| CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER (K131332) | Cardiosolutions, Inc. | 2013-07-19 |
| THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K131300) | Access Scientific, LLC | 2013-06-07 |
| VALVED TEARAWAY INTRODUCER GENERATION II (K124046) | Medical Components, Inc. | 2013-06-03 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH (K130559) | Great Batch Medical | 2013-05-24 |
| SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM (K121404) | Onset Medical Corporation | 2013-05-03 |
| SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING (K123990) | Medtronic Vascular | 2013-04-26 |
| MICROSLIDER TEARAWAY INTRODUCER SET (K123430) | Galt Medical Corp. | 2013-04-12 |
| AXERA 2 ACCESS SYSTEM (K123618) | Arstasis, Inc. | 2013-03-24 |
| PERCUTANEOUS INTRODUCER KIT (K123974) | Teleflex, Inc. | 2013-02-21 |
| EQUAFLOW MULTIVALVE INFUSION CATHETER (K123235) | Cook Incorporated | 2013-02-14 |
| HEARTSPAN STEERABLE INTRODUCER KIT (K122431) | Thomas Medical Products, Inc. | 2013-01-29 |
| AXERA 2 ACCESS SYSTEM MODEL AXE200 (K123135) | Arstasis, Inc. | 2013-01-28 |
| REPROCESSED STEERABLE INTRODUCER (K123334) | Stryker Sustainability Solutions, Inc. | 2013-01-24 |
| SUREFLEX STEERABLE GUIDING SHEATH KIT (K122926) | Baylis Medical Co., Inc. | 2013-01-24 |
| ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER (K122854) | Arrow International (Subsidiary of Teleflex Inc.) | 2013-01-04 |
| DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (K122958) | Oscor, Inc. | 2012-12-13 |
| STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (K122960) | Oscor, Inc. | 2012-12-13 |
| GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ (K122980) | Terumo Medical Corporation | 2012-12-11 |
| GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING (K121234) | W. L. Gore & Associates, Inc. | 2012-11-20 |
| PTFE SUPER SHEATH INTRODUCER (K120617) | Martech Medical Products | 2012-11-19 |
| SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS (K121504) | Togo Medikit Co., Ltd. | 2012-09-27 |
| INTRODUCER SET, MODEL ADELANTE-S SERIES (K122084) | Oscor, Inc. | 2012-08-29 |
| LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM (K111603) | Ep Dynamics, Inc. | 2012-08-23 |
| EDWARDS PERCUTANEOUS SHEATH INTRODUCER (K121185) | Edwards Lifesciences, LLC | 2012-08-22 |
| PRELUDE 7F SHORT SHEATH INTRODUCER (K122190) | Merit Medical Systems, Inc. | 2012-08-17 |
| CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS (K120158) | Thomas Medical Products, Inc. | 2012-08-14 |
| HQS INTRODUCER (K113849) | Alseal | 2012-07-31 |
| THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL (K121748) | Access Scientific, Inc. | 2012-07-27 |
| STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (K120459) | Oscor, Inc. | 2012-06-29 |
| AXERA ACCESS SYSTEM (K121521) | Arstasis, Inc. | 2012-06-21 |
| GORE DRYSEAL SHEATH (K120428) | W. L. Gore & Associates, Inc. | 2012-04-20 |
| TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT (K112398) | Galt Medical | 2012-04-12 |
| UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR (K112887) | Upstream Peripheral Technologies | 2012-03-21 |
| AFX INTRODUCER SYSTEM (K120212) | Endologix, Inc. | 2012-02-09 |
| SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS (K112407) | Smiths Medical MD, Inc. | 2012-02-09 |
| VASCULAR SONO (K113196) | PAJUNK GmbH Medizintechnologie | 2012-02-06 |
| RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT (K110051) | Great Batch Medical | 2012-02-02 |
| TRANSRADIAL ARTERY ACCESS DEVICES (K112554) | Teleflexmedical, Inc. | 2011-11-18 |
| NEXGEN EXPANDABLE CATHETER (K102925) | Nexgen Medical Systems, Inc. | 2011-11-10 |
| AXERA ACCESS SYSTEM (K113110) | Arstasis, Inc. | 2011-11-09 |
| PINNACLE PRECISION ACCESS SYSTEM (K111606) | Terumo Medical Corp. | 2011-10-03 |
| AGILLS PF DELIVERY SYSTEM (K111943) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-09-29 |
| THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K111417) | Access Scientific, Inc. | 2011-07-15 |
| ENDOLOGIX AFX INTRODUCER SYSTEM (K111747) | Endologix, Inc. | 2011-07-12 |
| THE PICC WAND (R) PEELABLE SAFETY INTRODUCER (K111138) | Access Scientific, Inc. | 2011-06-22 |
| ENGAGE/ENGAGE TR INTRODUCERS (K111092) | St Jude Medical | 2011-06-09 |
| AFX INTRODUCER SYSTEM (K110090) | Endologix, Inc. | 2011-05-26 |
| AGILIS NXT STEERABLE INTRODUCER (K110450) | St Jude Medical | 2011-05-10 |
| AGILIS ES STEERABLE INTRODUCER (K103083) | St Jude Medical | 2011-04-08 |
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K102948) | Baylis Medical Co., Inc. | 2011-04-01 |
| THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K101422) | Access Scientific, Inc. | 2011-03-22 |
| FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 (K100799) | Contract Medical Intl. GmbH | 2011-02-25 |
| ARSTASIS ONE LATCHWIRE ACCESS SYSTEM (K103143) | Arstasis, Inc. | 2011-02-02 |
| VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V (K101604) | Vascular Solutions, Inc. | 2011-01-24 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX (K101784) | Great Batch Medical | 2010-11-26 |
| PTFE PORTABLE INTRODUCER (K102540) | Great Batch Medical | 2010-11-16 |
| DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (K101497) | Oscor, Inc. | 2010-10-20 |
| ARSTASIS ACCESS SYSTEM (K102728) | Arstasis, Inc. | 2010-10-07 |
| 6F ENGAGE/ENGAGE TR INTRODUCER (K101883) | St Jude Medical | 2010-09-07 |
| PICC WAND PEELABLE SAFETY INTRODUCER (K101150) | Access Scientific, Inc. | 2010-08-13 |
| THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (K100819) | Onset Medical Corporation | 2010-08-02 |
| GLIDESHEATH (K102008) | Terumo Medical Corp. | 2010-07-21 |
| RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 (K093877) | Edwards Lifesciences, LLC | 2010-07-01 |