| Glidesheath Slender Tibial Pedal Kit (K193160) | Terumo Medical Coporation | 2019-12-03 |
| Impella CP Introducer (K192769) | Abiomed, Inc. | 2019-11-18 |
| AcQRef Introducer Sheath (K192106) | Acutus Medical, Inc. | 2019-09-03 |
| 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (K191871) | Boston Scientific Corporation | 2019-08-07 |
| Epicardial Access System (K191546) | Baylis Medical Company, Inc. | 2019-08-02 |
| Steerable Introducer (K191190) | Freudenberg Medical, LLC | 2019-08-01 |
| The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model (K183066) | Access Scientific, LLC | 2019-07-25 |
| FlexSeal Introducer Sheath with Hydrophilic Coating (K190628) | Freudenberg Medical Mis, Inc. | 2019-05-30 |
| VersaCross Transseptal Sheath (K183655) | Baylis Medical Company, Inc. | 2019-05-20 |
| D'Vill Introducer (K190974) | NuMED, Inc. | 2019-05-14 |
| BioCardia 8.5 F Avance Steerable lntroducer (K190941) | Biocardia, Inc. | 2019-05-06 |
| Guide Sheath (K190644) | Surmodics,Inc. | 2019-04-18 |
| VersaCross Steerable Sheath, VersaCross Transseptal Dilator (K190688) | Baylis Medical Company, Inc. | 2019-04-17 |
| M-Y Sheath (K190369) | Ram Medical Innovations, Inc. | 2019-04-17 |
| transGlideXT Expandable Introducer (K181817) | Transaortic Medical, Inc. | 2019-03-26 |
| iSLEEVE Introducer Set (K190184) | Boston Scientific | 2019-03-07 |
| Endophys Pressure Sensing Sheath (K190098) | Endophys Holdings, LLC | 2019-03-07 |
| DuraSheath Introducer Sheath System (K181463) | Contract Medical International, GmbH | 2018-12-13 |
| TSI Transseptal Introducer (K181031) | Pressure Products Medical Device Manufacturing, LLC | 2018-10-26 |
| Endophys Pressure Sensing Sheath Kit (K180620) | Endophys Holdings, LLC | 2018-10-12 |
| TSP Crosser Transseptal Access System (K181088) | Transseptal Solutions , Ltd. | 2018-09-28 |
| The CVC WAND Safety Introducer with Valved Peelable Sheath (K182243) | Access Scientific, LLC | 2018-09-18 |
| RAIN Sheath Transradial (K181592) | Cordis Corporation | 2018-08-15 |
| Glidesheath Slender Tibial Pedal Kit (K181237) | Terumo Medical Corporation | 2018-08-03 |
| RadialSeal Introducer Kit (K181855) | Great Batch Medical | 2018-07-26 |
| iSLEEVE Introducer Set (K180785) | Boston Scientific Corporation | 2018-06-22 |
| Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (K171609) | Cook Incorporated | 2018-06-04 |
| VSI Micro-Introducer Kit (K180913) | Vascular Solutions, Inc. | 2018-05-09 |
| Glidesheath Slender (K173831) | Terumo Medical Corporation | 2018-05-08 |
| Micropuncture Pedal Access Set (K172980) | Cook Incorporated | 2018-05-03 |
| RAILWAY Sheathless Access System (K180081) | Cordis Corporation | 2018-04-18 |
| Performer Guiding Sheath (K171988) | Cook Incorporated | 2018-03-30 |
| Transjugular Liver Access Sets (K171820) | Cook Incorporated | 2018-03-09 |
| Type I, Type II, Type III, Type IV (K172331) | Lepu Medical Technology (Beijing) Co., Ltd. | 2018-03-02 |
| Prelude IDeal Hydrophilic Sheath Introducer (K173750) | Merit Medical Systems, Inc. | 2018-02-15 |
| AcQRef Introducer Sheath (K171557) | Acutus Medical, Inc. | 2018-02-06 |
| Elite HV Radial (K173287) | Galt Medical Corp. | 2017-12-21 |
| Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design (K171275) | Cook Incorporated | 2017-12-20 |
| Peel-Away Introducer Set (K173685) | Cook Incorporated | 2017-12-20 |
| Sentrant Introducer Sheath with Hydrophilic Coating (K171866) | Medtronic Vascular, Inc. | 2017-12-20 |
| Endophys Pressure Sensing Sheath Kit- 8F (K173399) | Endophys Holdings, LLC | 2017-11-30 |
| Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (K172995) | Terumo Medical Corporation | 2017-11-21 |
| Performer Introducer (K173068) | Cook Incorporated | 2017-11-17 |
| D'Vill Introducer (K171206) | NuMED, Inc. | 2017-10-20 |
| R2P Destination Slender Guiding Sheath (K171491) | Terumo Medical Corporation | 2017-10-05 |
| Shoocin Introducer Kit (K172099) | Lepu Medical Technology (Beijing) Co., Ltd. | 2017-10-05 |
| Peel-Away Introducer Set (K170020) | Cook Incorporated | 2017-09-28 |
| Prelude Pursuit Splittable Sheath Introducer (K172117) | Merit Medical Systems, Inc. | 2017-09-11 |
| Liver Access and Biopsy Sets (K171853) | Cook Incorporated | 2017-08-24 |
| Performer Introducer (K171999) | Cook Incorporated | 2017-07-31 |
| CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (K170997) | Biosense Webster, Inc. | 2017-07-25 |
| Mini Stick ENVI Non-Vascular Introducer Kit (K170775) | AngioDynamics, Inc. | 2017-07-19 |
| VenaCure EVLT NeverTouch Direct Introducer Sheath (K170695) | AngioDynamics, Inc. | 2017-05-30 |
| EpiAccess System (K170831) | Epiep, Inc. | 2017-05-09 |
| Guider Catheter Introducer (K171081) | Rhythm Xience, Inc. (Rxi) | 2017-05-09 |
| HeartSpan Steerable Sheath Introducer (K170668) | Merit Medical Systems, Inc. | 2017-04-05 |
| Vado Steerable Sheath (K160721) | Kalila Medical, Inc. | 2017-03-07 |
| Flextra Steerable Introducer (K170373) | Rhythm Xience, Inc. (Rxi) | 2017-02-27 |
| FlexCath Select Steerable Shealth and Dilator (K163268) | Medtronic Cryocath, LP | 2017-02-02 |
| Vado Bi-Directional Steerable Sheath (K162427) | Kalila Medical, Inc. | 2017-01-27 |
| InTRAkit (K162097) | Medtronic Vascular | 2016-11-17 |
| the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model (K162322) | Access Scientific, LLC | 2016-11-17 |
| Pinpoint GT Introducer Needle (K162769) | C.R. Bard, Inc. | 2016-11-04 |
| TXM Guiding Sheath (K153771) | Texasmedical Technologies, Inc. | 2016-09-13 |
| Edwards eSheath Introducer Set (K162184) | Edward Lifesciences | 2016-09-02 |
| HQS Introducer (Model 2064-HQS) (K153494) | Alseal | 2016-08-25 |
| GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle (K152913) | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2016-07-21 |
| FlexSeal Introducer Sheath with Hydrophilic Coating (K161659) | Libramedical, Inc. | 2016-07-15 |
| Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (K153533) | Galt Medical Corp. | 2016-07-05 |
| Halo One Thin-Walled Guiding Sheath (K161183) | C.R. Bard, Inc. | 2016-06-03 |
| Nanostim Introducer Kit (K161102) | St. Jude Medical, Inc. | 2016-05-19 |
| GORE DrySeal Flex Introducer Sheath (K160254) | W. L. Gore & Associates, Inc. | 2016-05-12 |
| The Nanostim Introducer Kit (K160716) | St. Jude Medical, Inc. | 2016-04-14 |
| transGlide Expandable Introducer (K152194) | Transaortic Medical, Inc. | 2016-04-07 |
| Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select (K153430) | Cook Incorporated | 2016-03-07 |
| Endophys Pressure Sensing Sheath Kit (K160272) | Endophys, Inc. | 2016-03-04 |
| PTFE Super Sheath Introducer 2.1 (K153246) | Medcomp (Medical Components, Inc.) | 2016-02-12 |
| Fortress Introducer Sheath SYstem (K153197) | Contract Medical International, GmbH | 2016-01-11 |
| SoloPath Re-Collapsible Access System (K152498) | Onset Medical Corporation | 2016-01-05 |
| Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle (K151936) | Synaptic Medical Limited | 2015-12-04 |
| Glidesheath (K152173) | Terumo Medical Corporation | 2015-12-01 |
| Edwards eSheath Introducer Set (K152225) | Edwards Lifesciences | 2015-11-24 |
| Prelude SNAP Splittable Hydrophilic Sheath Introducer (K152381) | Merit Medical Systems, Inc. | 2015-10-30 |
| SonoStik IV Guide Wire Introducer (K152177) | Sonostik, LLC | 2015-10-01 |
| Destino Reach (K151951) | Oscor, Inc. | 2015-09-22 |
| 5.5 F Worley Advanced LVI Lateral Vein Introducer (K152116) | Merit Medical Systems, Inc. | 2015-08-27 |
| Flexor Radial Hydrophilic Introducer Access Set (K152044) | Cook Incorporated | 2015-08-14 |
| Confida Adaptive Sheath (K152054) | Medtronic, Inc. | 2015-08-07 |
| Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer (K142829) | Cook Incorporated | 2015-07-28 |
| Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set (K142819) | Cook Incorporated | 2015-07-24 |
| DuraSheath Introducer Sheath System (K142357) | Contract Medical International, GmbH | 2015-06-25 |
| PreludeEASE Hydrophilic Sheath Introducer (K150257) | Merit Medical Systems, Inc. | 2015-06-19 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| PINPOINT GT SAFETY INTRODUCER NEEDLE (K142445) | C.R. Bard, Inc. | 2015-04-13 |
| Prelude SNAP Splittable Sheath Introducer (K143255) | Merit Medical Systems, Inc. | 2015-04-09 |
| ENDOPHYS PRESSURE SENSING SHEATH KIT (K141275) | Endophys, Inc. | 2015-01-07 |
| FIRSTSTIC N INTRODUCER (K141969) | Argon Medical Devices, Inc. | 2014-12-19 |
| NANOSTIM INTRODUCER KIT (K140793) | St. Jude Medical, Inc. | 2014-12-17 |
| TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT (K140768) | Lepu Medical Technology (Bejing) Co., Ltd. | 2014-11-25 |
| GLIDESHEATH SLENDER (K142183) | Terumo Medical Corporation | 2014-11-21 |