Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2019 | K192313 | Halo One Thin-Walled Guiding Sheath C.R. Bard, Inc., IE | DYB |
| Dec 3, 2019 | K193160 | Glidesheath Slender Tibial Pedal Kit Terumo Medical Coporation | DYB |
| Nov 18, 2019 | K192769 | Impella CP Introducer Abiomed, Inc. | DYB |
| Sep 3, 2019 | K192106 | AcQRef Introducer Sheath Acutus Medical, Inc. | DYB |
| Aug 7, 2019 | K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set Boston Scientific Corporation | DYB |
| Aug 2, 2019 | K191546 | Epicardial Access System Baylis Medical Company, Inc., CA | DYB |
| Aug 1, 2019 | K191190 | Steerable Introducer Freudenberg Medical, LLC | DYB |
| Jul 25, 2019 | K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Access Scientific, LLC | DYB |
| May 30, 2019 | K190628 | FlexSeal Introducer Sheath with Hydrophilic Coating Freudenberg Medical Mis, Inc. | DYB |
| May 20, 2019 | K183655 | VersaCross Transseptal Sheath Baylis Medical Company, Inc., CA | DYB |
| May 14, 2019 | K190974 | D'Vill Introducer NuMED, Inc. | DYB |
| May 6, 2019 | K190941 | BioCardia 8.5 F Avance Steerable lntroducer Biocardia, Inc. | DYB |
| Apr 18, 2019 | K190644 | Guide Sheath Surmodics,Inc. | DYB |
| Apr 17, 2019 | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator Baylis Medical Company, Inc., CA | DYB |
| Apr 17, 2019 | K190369 | M-Y Sheath Ram Medical Innovations, Inc. | DYB |
| Mar 26, 2019 | K181817 | transGlideXT Expandable Introducer Transaortic Medical, Inc. | DYB |
| Mar 7, 2019 | K190184 | iSLEEVE Introducer Set Boston Scientific | DYB |
| Mar 7, 2019 | K190098 | Endophys Pressure Sensing Sheath Endophys Holdings, LLC | DYB |
| Dec 13, 2018 | K181463 | DuraSheath Introducer Sheath System Contract Medical International, GmbH, DE | DYB |
| Oct 26, 2018 | K181031 | TSI Transseptal Introducer Pressure Products Medical Device Manufacturing, LLC | DYB |
| Oct 12, 2018 | K180620 | Endophys Pressure Sensing Sheath Kit Endophys Holdings, LLC | DYB |
| Sep 28, 2018 | K181088 | TSP Crosser Transseptal Access System Transseptal Solutions , Ltd., IL | DYB |
| Sep 18, 2018 | K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath Access Scientific, LLC | DYB |
| Aug 15, 2018 | K181592 | RAIN Sheath Transradial Cordis Corporation | DYB |
| Aug 3, 2018 | K181237 | Glidesheath Slender Tibial Pedal Kit Terumo Medical Corporation | DYB |
| Jul 26, 2018 | K181855 | RadialSeal Introducer Kit Great Batch Medical | DYB |
| Jun 22, 2018 | K180785 | iSLEEVE Introducer Set Boston Scientific Corporation | DYB |
| Jun 4, 2018 | K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set Cook Incorporated | DYB |
| May 9, 2018 | K180913 | VSI Micro-Introducer Kit Vascular Solutions, Inc. | DYB |
| May 8, 2018 | K173831 | Glidesheath Slender Terumo Medical Corporation | DYB |
| May 3, 2018 | K172980 | Micropuncture Pedal Access Set Cook Incorporated | DYB |
| Apr 18, 2018 | K180081 | RAILWAY Sheathless Access System Cordis Corporation | DYB |
| Mar 30, 2018 | K171988 | Performer Guiding Sheath Cook Incorporated | DYB |
| Mar 9, 2018 | K171820 | Transjugular Liver Access Sets Cook Incorporated | DYB |
| Mar 2, 2018 | K172331 | Type I, Type II, Type III, Type IV Lepu Medical Technology (Beijing) Co., Ltd., CN | DYB |
| Feb 15, 2018 | K173750 | Prelude IDeal Hydrophilic Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Feb 6, 2018 | K171557 | AcQRef Introducer Sheath Acutus Medical, Inc. | DYB |
| Dec 21, 2017 | K173287 | Elite HV Radial Galt Medical Corp. | DYB |
| Dec 20, 2017 | K173685 | Peel-Away Introducer Set Cook Incorporated | DYB |
| Dec 20, 2017 | K171866 | Sentrant Introducer Sheath with Hydrophilic Coating Medtronic Vascular, Inc. | DYB |
| Dec 20, 2017 | K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silh Cook Incorporated | DYB |
| Nov 30, 2017 | K173399 | Endophys Pressure Sensing Sheath Kit- 8F Endophys Holdings, LLC | DYB |
| Nov 21, 2017 | K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Terumo Medical Corporation | DYB |
| Nov 17, 2017 | K173068 | Performer Introducer Cook Incorporated | DYB |
| Oct 20, 2017 | K171206 | D'Vill Introducer NuMED, Inc. | DYB |
| Oct 5, 2017 | K172099 | Shoocin Introducer Kit Lepu Medical Technology (Beijing) Co., Ltd., CN | DYB |
| Oct 5, 2017 | K171491 | R2P Destination Slender Guiding Sheath Terumo Medical Corporation | DYB |
| Sep 28, 2017 | K170020 | Peel-Away Introducer Set Cook Incorporated | DYB |
| Sep 11, 2017 | K172117 | Prelude Pursuit Splittable Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Aug 24, 2017 | K171853 | Liver Access and Biopsy Sets Cook Incorporated | DYB |
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