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 |
|---|---|---|---|
| Jul 31, 2017 | K171999 | Performer Introducer Cook Incorporated | DYB |
| Jul 25, 2017 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc. | DYB |
| Jul 19, 2017 | K170775 | Mini Stick ENVI Non-Vascular Introducer Kit AngioDynamics, Inc. | DYB |
| May 30, 2017 | K170695 | VenaCure EVLT NeverTouch Direct Introducer Sheath AngioDynamics, Inc. | DYB |
| May 9, 2017 | K171081 | Guider Catheter Introducer Rhythm Xience, Inc. (Rxi) | DYB |
| May 9, 2017 | K170831 | EpiAccess System Epiep, Inc. | DYB |
| Apr 5, 2017 | K170668 | HeartSpan Steerable Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Mar 7, 2017 | K160721 | Vado Steerable Sheath Kalila Medical, Inc. | DYB |
| Feb 27, 2017 | K170373 | Flextra Steerable Introducer Rhythm Xience, Inc. (Rxi) | DYB |
| Feb 2, 2017 | K163268 | FlexCath Select Steerable Shealth and Dilator Medtronic Cryocath, LP | DYB |
| Jan 27, 2017 | K162427 | Vado Bi-Directional Steerable Sheath Kalila Medical, Inc. | DYB |
| Nov 17, 2016 | K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model Access Scientific, LLC | DYB |
| Nov 17, 2016 | K162097 | InTRAkit Medtronic Vascular | DYB |
| Nov 4, 2016 | K162769 | Pinpoint GT Introducer Needle C.R. Bard, Inc. | DYB |
| Sep 13, 2016 | K153771 | TXM Guiding Sheath Texasmedical Technologies, Inc. | DYB |
| Sep 2, 2016 | K162184 | Edwards eSheath Introducer Set Edward Lifesciences | DYB |
| Aug 25, 2016 | K153494 | HQS Introducer (Model 2064-HQS) Alseal, FR | DYB |
| Jul 21, 2016 | K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle Creganna Medical Aslo Business AS Cregganna Tactx Medical, IE | DYB |
| Jul 15, 2016 | K161659 | FlexSeal Introducer Sheath with Hydrophilic Coating Libramedical, Inc. | DYB |
| Jul 5, 2016 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer Galt Medical Corp. | DYB |
| Jun 3, 2016 | K161183 | Halo One Thin-Walled Guiding Sheath C.R. Bard, Inc., IE | DYB |
| May 19, 2016 | K161102 | Nanostim Introducer Kit St. Jude Medical, Inc. | DYB |
| May 12, 2016 | K160254 | GORE DrySeal Flex Introducer Sheath W. L. Gore & Associates, Inc. | DYB |
| Apr 14, 2016 | K160716 | The Nanostim Introducer Kit St. Jude Medical, Inc. | DYB |
| Apr 7, 2016 | K152194 | transGlide Expandable Introducer Transaortic Medical, Inc. | DYB |
| Mar 7, 2016 | K153430 | Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select Cook Incorporated | DYB |
| Mar 4, 2016 | K160272 | Endophys Pressure Sensing Sheath Kit Endophys, Inc. | DYB |
| Feb 12, 2016 | K153246 | PTFE Super Sheath Introducer 2.1 Medcomp (Medical Components, Inc.) | DYB |
| Jan 11, 2016 | K153197 | Fortress Introducer Sheath SYstem Contract Medical International, GmbH, DE | DYB |
| Jan 5, 2016 | K152498 | SoloPath Re-Collapsible Access System Onset Medical Corporation | DYB |
| Dec 4, 2015 | K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle Synaptic Medical Limited, CN | DYB |
| Dec 1, 2015 | K152173 | Glidesheath Terumo Medical Corporation | DYB |
| Nov 24, 2015 | K152225 | Edwards eSheath Introducer Set Edwards Lifesciences | DYB |
| Oct 30, 2015 | K152381 | Prelude SNAP Splittable Hydrophilic Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Oct 1, 2015 | K152177 | SonoStik IV Guide Wire Introducer Sonostik, LLC | DYB |
| Sep 22, 2015 | K151951 | Destino Reach Oscor, Inc. | DYB |
| Aug 27, 2015 | K152116 | 5.5 F Worley Advanced LVI Lateral Vein Introducer Merit Medical Systems, Inc. | DYB |
| Aug 14, 2015 | K152044 | Flexor Radial Hydrophilic Introducer Access Set Cook Incorporated | DYB |
| Aug 7, 2015 | K152054 | Confida Adaptive Sheath Medtronic, Inc. | DYB |
| Jul 28, 2015 | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Chec Cook Incorporated | DYB |
| Jul 24, 2015 | K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set Cook Incorporated | DYB |
| Jun 25, 2015 | K142357 | DuraSheath Introducer Sheath System Contract Medical International, GmbH, DE | DYB |
| Jun 19, 2015 | K150257 | PreludeEASE Hydrophilic Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Jun 5, 2015 | K150186 | Chariot Guiding Sheath Boston Scientific Corp | DYB |
| Apr 13, 2015 | K142445 | PINPOINT GT SAFETY INTRODUCER NEEDLE C.R. Bard, Inc. | DYB |
| Apr 9, 2015 | K143255 | Prelude SNAP Splittable Sheath Introducer Merit Medical Systems, Inc. | DYB |
| Jan 7, 2015 | K141275 | ENDOPHYS PRESSURE SENSING SHEATH KIT Endophys, Inc. | DYB |
| Dec 19, 2014 | K141969 | FIRSTSTIC N INTRODUCER Argon Medical Devices, Inc. | DYB |
| Dec 17, 2014 | K140793 | NANOSTIM INTRODUCER KIT St. Jude Medical, Inc. | DYB |
| Nov 25, 2014 | 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. | DYB |
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