FDA Product Code
FDA Product Code DYB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1340
510(k) Clearances — 706 records · page 2 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193160 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Coporation | 2019-12-03 | Special | PDF ↗ |
| K192769 | Impella CP Introducer | Abiomed, Inc. | 2019-11-18 | Traditional | PDF ↗ |
| K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2019-09-03 | Special | PDF ↗ |
| K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set | Boston Scientific Corporation | 2019-08-07 | Special | PDF ↗ |
| K191546 | Epicardial Access System | Baylis Medical Company, Inc. | 2019-08-02 | Traditional | PDF ↗ |
| K191190 | Steerable Introducer | Freudenberg Medical, LLC | 2019-08-01 | Traditional | PDF ↗ |
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model | Access Scientific, LLC | 2019-07-25 | Traditional | PDF ↗ |
| K190628 | FlexSeal Introducer Sheath with Hydrophilic Coating | Freudenberg Medical Mis, Inc. | 2019-05-30 | Traditional | PDF ↗ |
| K183655 | VersaCross Transseptal Sheath | Baylis Medical Company, Inc. | 2019-05-20 | Traditional | PDF ↗ |
| K190974 | D'Vill Introducer | NuMED, Inc. | 2019-05-14 | Special | PDF ↗ |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | Biocardia, Inc. | 2019-05-06 | Traditional | PDF ↗ |
| K190644 | Guide Sheath | Surmodics,Inc. | 2019-04-18 | Traditional | PDF ↗ |
| K190369 | M-Y Sheath | Ram Medical Innovations, Inc. | 2019-04-17 | Traditional | PDF ↗ |
| K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Company, Inc. | 2019-04-17 | Special | PDF ↗ |
| K181817 | transGlideXT Expandable Introducer | Transaortic Medical, Inc. | 2019-03-26 | Traditional | PDF ↗ |
| K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | 2019-03-07 | Special | PDF ↗ |
| K190184 | iSLEEVE Introducer Set | Boston Scientific | 2019-03-07 | Special | PDF ↗ |
| K181463 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2018-12-13 | Traditional | PDF ↗ |
| K181031 | TSI Transseptal Introducer | Pressure Products Medical Device Manufacturing, LLC | 2018-10-26 | Traditional | PDF ↗ |
| K180620 | Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC | 2018-10-12 | Special | PDF ↗ |
| K181088 | TSP Crosser Transseptal Access System | Transseptal Solutions , Ltd. | 2018-09-28 | Traditional | PDF ↗ |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | Access Scientific, LLC | 2018-09-18 | Special | PDF ↗ |
| K181592 | RAIN Sheath Transradial | Cordis Corporation | 2018-08-15 | Traditional | PDF ↗ |
| K181237 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Corporation | 2018-08-03 | Traditional | PDF ↗ |
| K181855 | RadialSeal Introducer Kit | Great Batch Medical | 2018-07-26 | Traditional | PDF ↗ |
| K180785 | iSLEEVE Introducer Set | Boston Scientific Corporation | 2018-06-22 | Traditional | PDF ↗ |
| K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | Cook Incorporated | 2018-06-04 | Traditional | PDF ↗ |
| K180913 | VSI Micro-Introducer Kit | Vascular Solutions, Inc. | 2018-05-09 | Traditional | PDF ↗ |
| K173831 | Glidesheath Slender | Terumo Medical Corporation | 2018-05-08 | Traditional | PDF ↗ |
| K172980 | Micropuncture Pedal Access Set | Cook Incorporated | 2018-05-03 | Traditional | PDF ↗ |
| K180081 | RAILWAY Sheathless Access System | Cordis Corporation | 2018-04-18 | Traditional | PDF ↗ |
| K171988 | Performer Guiding Sheath | Cook Incorporated | 2018-03-30 | Traditional | PDF ↗ |
| K171820 | Transjugular Liver Access Sets | Cook Incorporated | 2018-03-09 | Traditional | PDF ↗ |
| K172331 | Type I, Type II, Type III, Type IV | Lepu Medical Technology (Beijing) Co., Ltd. | 2018-03-02 | Traditional | PDF ↗ |
| K173750 | Prelude IDeal Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2018-02-15 | Special | PDF ↗ |
| K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2018-02-06 | Traditional | PDF ↗ |
| K173287 | Elite HV Radial | Galt Medical Corp. | 2017-12-21 | Traditional | PDF ↗ |
| K171275 | 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 | Cook Incorporated | 2017-12-20 | Special | PDF ↗ |
| K173685 | Peel-Away Introducer Set | Cook Incorporated | 2017-12-20 | Special | PDF ↗ |
| K171866 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular, Inc. | 2017-12-20 | Special | PDF ↗ |
| K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017-11-30 | Traditional | PDF ↗ |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | Terumo Medical Corporation | 2017-11-21 | Traditional | PDF ↗ |
| K173068 | Performer Introducer | Cook Incorporated | 2017-11-17 | Traditional | PDF ↗ |
| K171206 | D'Vill Introducer | NuMED, Inc. | 2017-10-20 | Traditional | PDF ↗ |
| K172099 | Shoocin Introducer Kit | Lepu Medical Technology (Beijing) Co., Ltd. | 2017-10-05 | Traditional | PDF ↗ |
| K171491 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2017-10-05 | Traditional | PDF ↗ |
| K170020 | Peel-Away Introducer Set | Cook Incorporated | 2017-09-28 | Traditional | PDF ↗ |
| K172117 | Prelude Pursuit Splittable Sheath Introducer | Merit Medical Systems, Inc. | 2017-09-11 | Traditional | PDF ↗ |
| K171853 | Liver Access and Biopsy Sets | Cook Incorporated | 2017-08-24 | Traditional | PDF ↗ |
| K171999 | Performer Introducer | Cook Incorporated | 2017-07-31 | Special | PDF ↗ |
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | Biosense Webster, Inc. | 2017-07-25 | Traditional | PDF ↗ |
| K170775 | Mini Stick ENVI Non-Vascular Introducer Kit | AngioDynamics, Inc. | 2017-07-19 | Traditional | PDF ↗ |
| K170695 | VenaCure EVLT NeverTouch Direct Introducer Sheath | AngioDynamics, Inc. | 2017-05-30 | Traditional | PDF ↗ |
| K171081 | Guider Catheter Introducer | Rhythm Xience, Inc. (Rxi) | 2017-05-09 | Traditional | PDF ↗ |
| K170831 | EpiAccess System | Epiep, Inc. | 2017-05-09 | Special | PDF ↗ |
| K170668 | HeartSpan Steerable Sheath Introducer | Merit Medical Systems, Inc. | 2017-04-05 | Special | PDF ↗ |
| K160721 | Vado Steerable Sheath | Kalila Medical, Inc. | 2017-03-07 | Traditional | PDF ↗ |
| K170373 | Flextra Steerable Introducer | Rhythm Xience, Inc. (Rxi) | 2017-02-27 | Traditional | PDF ↗ |
| K163268 | FlexCath Select Steerable Shealth and Dilator | Medtronic Cryocath, LP | 2017-02-02 | Traditional | PDF ↗ |
| K162427 | Vado Bi-Directional Steerable Sheath | Kalila Medical, Inc. | 2017-01-27 | Traditional | PDF ↗ |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | Access Scientific, LLC | 2016-11-17 | Traditional | PDF ↗ |
| K162097 | InTRAkit | Medtronic Vascular | 2016-11-17 | Traditional | PDF ↗ |
| K162769 | Pinpoint GT Introducer Needle | C.R. Bard, Inc. | 2016-11-04 | Special | PDF ↗ |
| K153771 | TXM Guiding Sheath | Texasmedical Technologies, Inc. | 2016-09-13 | Traditional | PDF ↗ |
| K162184 | Edwards eSheath Introducer Set | Edward Lifesciences | 2016-09-02 | Special | PDF ↗ |
| K153494 | HQS Introducer (Model 2064-HQS) | Alseal | 2016-08-25 | Traditional | PDF ↗ |
| K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2016-07-21 | Traditional | PDF ↗ |
| K161659 | FlexSeal Introducer Sheath with Hydrophilic Coating | Libramedical, Inc. | 2016-07-15 | Traditional | PDF ↗ |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | Galt Medical Corp. | 2016-07-05 | Traditional | PDF ↗ |
| K161183 | Halo One Thin-Walled Guiding Sheath | C.R. Bard, Inc. | 2016-06-03 | Traditional | PDF ↗ |
| K161102 | Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016-05-19 | Special | PDF ↗ |
| K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-05-12 | Traditional | PDF ↗ |
| K160716 | The Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016-04-14 | Special | PDF ↗ |
| K152194 | transGlide Expandable Introducer | Transaortic Medical, Inc. | 2016-04-07 | Traditional | PDF ↗ |
| K153430 | Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select | Cook Incorporated | 2016-03-07 | Special | PDF ↗ |
| K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016-03-04 | Special | PDF ↗ |
| K153246 | PTFE Super Sheath Introducer 2.1 | Medcomp (Medical Components, Inc.) | 2016-02-12 | Special | PDF ↗ |
| K153197 | Fortress Introducer Sheath SYstem | Contract Medical International, GmbH | 2016-01-11 | Special | PDF ↗ |
| K152498 | SoloPath Re-Collapsible Access System | Onset Medical Corporation | 2016-01-05 | Traditional | PDF ↗ |
| K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle | Synaptic Medical Limited | 2015-12-04 | Traditional | PDF ↗ |
| K152173 | Glidesheath | Terumo Medical Corporation | 2015-12-01 | Traditional | PDF ↗ |
| K152225 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2015-11-24 | Traditional | PDF ↗ |
| K152381 | Prelude SNAP Splittable Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2015-10-30 | Special | PDF ↗ |
| K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015-10-01 | Traditional | PDF ↗ |
| K151951 | Destino Reach | Oscor, Inc. | 2015-09-22 | Special | PDF ↗ |
| K152116 | 5.5 F Worley Advanced LVI Lateral Vein Introducer | Merit Medical Systems, Inc. | 2015-08-27 | Special | PDF ↗ |
| K152044 | Flexor Radial Hydrophilic Introducer Access Set | Cook Incorporated | 2015-08-14 | Special | PDF ↗ |
| K152054 | Confida Adaptive Sheath | Medtronic, Inc. | 2015-08-07 | Traditional | PDF ↗ |
| K142829 | 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 | Cook Incorporated | 2015-07-28 | Traditional | PDF ↗ |
| K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | Cook Incorporated | 2015-07-24 | Traditional | PDF ↗ |
| K142357 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2015-06-25 | Traditional | PDF ↗ |
| K150257 | PreludeEASE Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2015-06-19 | Special | PDF ↗ |
| K150186 | Chariot Guiding Sheath | Boston Scientific Corp | 2015-06-05 | Traditional | PDF ↗ |
| K142445 | PINPOINT GT SAFETY INTRODUCER NEEDLE | C.R. Bard, Inc. | 2015-04-13 | Traditional | PDF ↗ |
| K143255 | Prelude SNAP Splittable Sheath Introducer | Merit Medical Systems, Inc. | 2015-04-09 | Traditional | PDF ↗ |
| K141275 | ENDOPHYS PRESSURE SENSING SHEATH KIT | Endophys, Inc. | 2015-01-07 | Traditional | PDF ↗ |
| K141969 | FIRSTSTIC N INTRODUCER | Argon Medical Devices, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K140793 | NANOSTIM INTRODUCER KIT | St. Jude Medical, Inc. | 2014-12-17 | Traditional | PDF ↗ |
| K140768 | TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT | Lepu Medical Technology (Bejing) Co., Ltd. | 2014-11-25 | Traditional | PDF ↗ |
| K142183 | GLIDESHEATH SLENDER | Terumo Medical Corporation | 2014-11-21 | Special | PDF ↗ |
Product code DYB · Class II · Cardiovascular. Data: openFDA.