| COAXIAL INTRODUCER SET (K101399) | Martech Medical Products | 2010-06-17 |
| A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH (K092097) | A.B. Korkor Medical, Inc. | 2010-05-06 |
| ARSTASIS ACCESS SYSTEM (K100615) | Arstasis, Inc. | 2010-03-30 |
| GORE DRYSEAL SHEATH (K093791) | W. L. Gore & Associates, Inc. | 2010-03-22 |
| OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER (K093232) | Great Batch Medical | 2010-03-15 |
| ITG VASCULAR ACCESS SYSTEM, MODEL 300 (K091006) | Arstasis, Inc. | 2010-02-25 |
| FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER (K093026) | Footprint Medical | 2010-02-24 |
| THE PICC WAND PEELABLE SAFETY INTRODUCER (K093022) | Access Scientific, Inc. | 2010-01-20 |
| MICRO-STICK SET (K091954) | Medcomp | 2010-01-08 |
| GDS-DCS (K091367) | Guided Delivery Systems | 2009-11-05 |
| ENGAGE TR INTRODUCER (K093130) | St Jude Medical | 2009-11-04 |
| PTFE PEELABLE INTRODUCER (K093023) | Great Batch Medical | 2009-10-29 |
| ENGAGE/ENGAGE TR (K092575) | St Jude Medical | 2009-10-08 |
| SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (K092014) | Onset Medical Corporation | 2009-10-08 |
| VALVED TEARWAY INTRODUCER (K090394) | Medcomp | 2009-09-01 |
| AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 (K090867) | Ep Dynamics, Inc. | 2009-07-30 |
| MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S (K090114) | Oscor, Inc. | 2009-06-04 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K091329) | Terumo Medical Corp. | 2009-05-29 |
| ULTIMUM/ENGAGE/ENGAGE TR (K091137) | St Jude Medical | 2009-04-22 |
| BIOCARDIA MORPH SHEATH GUIDE (K090999) | Biocardia, Inc. | 2009-04-15 |
| THE WAND MICROACCESS SAFETY INTRODUCER (K090372) | Access Scientific, Inc. | 2009-03-30 |
| MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 (K083855) | Acumen Medical, Inc. | 2009-02-17 |
| CROSSOVER (K083269) | Thomas Medical Products, Inc. | 2009-02-03 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 (K083402) | St Jude Medical | 2008-12-15 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 (K081645) | St Jude Medical | 2008-12-09 |
| SPECTRA GUIDEWIRE INTRODUCER NEEDLE (K082580) | Spectra Medical Devices, Inc. | 2008-12-08 |
| THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 (K081697) | Access Scientific, Inc. | 2008-12-04 |
| AGILIS NXT STEERABLE INTRODUCER (K083083) | St Jude Medical | 2008-11-06 |
| PINNACLE ROII INTRODUCER SHEATH (K082847) | Terumo Medical Corp. | 2008-10-29 |
| PRELUDE SHORT SHEATH INTRODUCER (K082063) | Merit Medical Systems, Inc. | 2008-10-15 |
| GLIDESHEATH (K082644) | Terumo Medical Corp. | 2008-09-18 |
| PTFE INTERLOCK PEELABLE INTRODUCERS (K081394) | Enpath Medical, Inc. | 2008-09-15 |
| GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K082356) | W. L. Gore & Associates, Inc. | 2008-08-28 |
| DESTINATION RENAL GUIDING SHEATH (K081045) | Terumo Medical Corp. | 2008-05-28 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K081046) | Terumo Medical Corp. | 2008-05-21 |
| REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) (K081341) | Thomas Medical Products, Inc. | 2008-05-14 |
| BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K073434) | Bipore, Inc. | 2008-04-01 |
| MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 (K080500) | Acumen Medical, Inc. | 2008-03-13 |
| CONVOY ADVANCED DELIVERY SHEATH (K072719) | Boston Scientific Corp | 2008-03-07 |
| DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K080415) | Terumo Medical Corp. | 2008-03-07 |
| INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S (K073100) | Oscor, Inc. | 2007-11-30 |
| VIAPEEL PEELABLE INTRODUCER (K072248) | Enpath Medical, Inc. | 2007-11-09 |
| PTFE PEEL AWAY MICROINTRODUCER (K072130) | Intromed | 2007-10-31 |
| EXPANDING VASCULAR SHEATH (K070865) | Applied Medical | 2007-10-23 |
| PERIPHERAL GUIDING SHEATH (K070816) | Micrus Design Technology, Inc. | 2007-09-19 |
| INTRAVASCULAR INTRODUCER SYSTEM (K063658) | Applied Medical Resources Corp. | 2007-09-12 |
| STIFFER COAXIAL MICRO-INTRODUCER KIT (K071574) | Enpath Medical, Inc. | 2007-07-05 |
| ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 (K070417) | St Jude Medical | 2007-06-05 |
| MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 (K070396) | Acumen Medical, Inc. | 2007-05-22 |
| STRADA CAROTID GUIDING SHEATH (K070166) | St Jude Medical | 2007-04-06 |
| BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 (K062852) | Onset Medical Corporation | 2007-02-23 |
| ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY (K070197) | Acumen Medical, Inc. | 2007-02-23 |
| ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX (K063182) | Enpath Medical, Inc. | 2006-12-21 |
| MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH (K062446) | Terumo Medical Corp. | 2006-10-23 |
| MODIFICATION TO GLIDESHEATH (K062858) | Terumo Medical Corp. | 2006-10-20 |
| MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 (K062145) | Acumen Medical, Inc. | 2006-08-23 |
| FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER (K061015) | St Jude Medical | 2006-08-03 |
| MEDCOMP VASCU-SHEATH II (K053092) | Medcomp | 2006-08-01 |
| AGILIS NXT STEERABLE INTRODUCER (K061363) | St Jude Medical | 2006-07-12 |
| STARCLOSE INTRODUCER SET MODEL- 1002 (K060902) | Abbott Vascular, Inc. | 2006-07-07 |
| CAROTID ACCESS KIT (K060666) | Terumo Medical Corp. | 2006-06-29 |
| ACUMEN SINGLE-LUMEN DELIVERY SHEATH (K053400) | Acumen Medical, Inc. | 2006-06-19 |
| INTRODUCER ASSEMBLY WITH ROTATOR LOCK (K060519) | Teleflex Medical | 2006-05-05 |
| SUPER SHEATH XL INTRODUCER SHEATH (K060190) | Togo Medikit Co., Ltd. | 2006-04-04 |
| BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K051513) | Bipore, Inc. | 2005-12-07 |
| SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER (K052644) | St Jude Medical | 2005-12-05 |
| VYGON MICRO-ACCESS SAFETY INTRODUCER KIT (K051248) | Vygon Corp. | 2005-10-27 |
| DESTINATION CAROTID GUIDING SHEATH (K052185) | Terumo Medical Corp. | 2005-09-06 |
| MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 (K051515) | Acumen Medical, Inc. | 2005-09-01 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K051601) | Terumo Medical Corp. | 2005-08-04 |
| INNER-LOCK INTRODUCER SHEATH (K051468) | Rex Medical | 2005-08-04 |
| APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 (K051096) | St. Jude Medical, Daig Division, Inc. | 2005-05-17 |
| PREMERE DELIVERY SHEATH, MODEL PDS (K043084) | Velocimed, Inc. | 2005-05-02 |
| SECURELOC; ADVANCINTRODUCER (K050023) | Specialized Health Products, Inc. | 2005-02-18 |
| SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 (K042308) | Facile Medical, Inc. | 2005-02-17 |
| LARGE BORE SPLITTABLE INTRODUCER KIT (K043438) | Thomas Medical Products, Inc. | 2005-02-15 |
| CATHETER INTRODUCER (K043525) | Galt Medical Corp. | 2005-02-09 |
| MODIFIED ACUMEN SHEATH, MODEL TTWO767 (K050015) | Acumen Medical, Inc. | 2005-02-03 |
| AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 (K042623) | St. Jude Medical, Daig Division, Inc. | 2005-01-27 |
| MODIFICATION TO SHORT INTRODUCER SHEATH (K042399) | Rex Medical, L.P. | 2004-12-17 |
| ENPATH SAFETY INTRODUCER (K041708) | Enpath Medical Incorporated | 2004-11-30 |
| ACUMEN SHEATH, MODEL TTW7807 (K042376) | Acumen Medical, Inc. | 2004-10-26 |
| INTRAVASCULAR ACCESS INTRODUCER SHEATH (K041506) | Applied Medical Resources Corp. | 2004-10-15 |
| AIRGUARD VALVED INTRODUCER (K042036) | C.R. Bard, Inc. | 2004-08-23 |
| ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT (K040728) | AngioDynamics, Inc. | 2004-06-18 |
| MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM (K040713) | Thomas Medical Products, Inc. | 2004-06-01 |
| MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 (K040552) | Cryocor, Inc. | 2004-05-28 |
| SAFETYNET GUIDEWIRE INTRODUCER (K040029) | Injectimed, Inc. | 2004-04-05 |
| NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC (K034025) | Nmt Medical, Inc. | 2004-03-26 |
| MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (K040150) | Medamicus, Inc. | 2004-02-18 |
| INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER (K033527) | B.Braun Medical, Inc. | 2004-02-05 |
| MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH (K034061) | Boston Scientific Corp | 2004-01-30 |
| GLIDESHEATH (K033681) | Terumo Corp. | 2003-12-11 |
| CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W (K031922) | Merit Medical Systems, Inc. | 2003-10-01 |
| SHORT INTRODUCER SHEATH (K032569) | Rex Medical | 2003-09-16 |
| SELDINGER SAFETY NEEDLE INTRODUCER (K032404) | Hdc Corp. | 2003-09-10 |
| PATHWAY ACCESS SHEATH CATHETER (K030734) | Vertelink Corporation | 2003-09-10 |
| GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K032073) | W. L. Gore & Associates, Inc. | 2003-08-13 |
| APEEL CS CATHETER DELIVERY SYSTEM (K031906) | St Jude Medical | 2003-07-18 |
| SAFETY INTRODUCER NEEDLE (K030135) | B.Braun Medical, Inc. | 2003-07-15 |