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 |
|---|---|---|---|
| Apr 6, 2007 | K070166 | STRADA CAROTID GUIDING SHEATH St Jude Medical | DYB |
| Feb 23, 2007 | K070197 | ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY Acumen Medical, Inc. | DYB |
| Feb 23, 2007 | K062852 | BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 Onset Medical Corporation | DYB |
| Dec 21, 2006 | K063182 | ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX Enpath Medical, Inc. | DYB |
| Oct 23, 2006 | K062446 | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH Terumo Medical Corp. | DYB |
| Oct 20, 2006 | K062858 | MODIFICATION TO GLIDESHEATH Terumo Medical Corp. | DYB |
| Aug 23, 2006 | K062145 | MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 Acumen Medical, Inc. | DYB |
| Aug 3, 2006 | K061015 | FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER St Jude Medical | DYB |
| Aug 1, 2006 | K053092 | MEDCOMP VASCU-SHEATH II Medcomp | DYB |
| Jul 12, 2006 | K061363 | AGILIS NXT STEERABLE INTRODUCER St Jude Medical | DYB |
| Jul 7, 2006 | K060902 | STARCLOSE INTRODUCER SET MODEL- 1002 Abbott Vascular, Inc. | DYB |
| Jun 29, 2006 | K060666 | CAROTID ACCESS KIT Terumo Medical Corp. | DYB |
| Jun 19, 2006 | K053400 | ACUMEN SINGLE-LUMEN DELIVERY SHEATH Acumen Medical, Inc. | DYB |
| May 5, 2006 | K060519 | INTRODUCER ASSEMBLY WITH ROTATOR LOCK Teleflex Medical | DYB |
| Apr 4, 2006 | K060190 | SUPER SHEATH XL INTRODUCER SHEATH Togo Medikit Co., Ltd. | DYB |
| Dec 7, 2005 | K051513 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. | DYB |
| Dec 5, 2005 | K052644 | SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER St Jude Medical | DYB |
| Oct 27, 2005 | K051248 | VYGON MICRO-ACCESS SAFETY INTRODUCER KIT Vygon Corp. | DYB |
| Sep 6, 2005 | K052185 | DESTINATION CAROTID GUIDING SHEATH Terumo Medical Corp. | DYB |
| Sep 1, 2005 | K051515 | MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 Acumen Medical, Inc. | DYB |
| Aug 4, 2005 | K051601 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Aug 4, 2005 | K051468 | INNER-LOCK INTRODUCER SHEATH Rex Medical | DYB |
| May 17, 2005 | K051096 | APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 St. Jude Medical, Daig Division, Inc. | DYB |
| May 2, 2005 | K043084 | PREMERE DELIVERY SHEATH, MODEL PDS Velocimed, Inc. | DYB |
| Feb 18, 2005 | K050023 | SECURELOC; ADVANCINTRODUCER Specialized Health Products, Inc. | DYB |
| Feb 17, 2005 | K042308 | SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 Facile Medical, Inc. | DYB |
| Feb 15, 2005 | K043438 | LARGE BORE SPLITTABLE INTRODUCER KIT Thomas Medical Products, Inc. | DYB |
| Feb 9, 2005 | K043525 | CATHETER INTRODUCER Galt Medical Corp. | DYB |
| Feb 3, 2005 | K050015 | MODIFIED ACUMEN SHEATH, MODEL TTWO767 Acumen Medical, Inc. | DYB |
| Jan 27, 2005 | K042623 | AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 St. Jude Medical, Daig Division, Inc. | DYB |
| Dec 17, 2004 | K042399 | MODIFICATION TO SHORT INTRODUCER SHEATH Rex Medical, L.P. | DYB |
| Nov 30, 2004 | K041708 | ENPATH SAFETY INTRODUCER Enpath Medical Incorporated | DYB |
| Oct 26, 2004 | K042376 | ACUMEN SHEATH, MODEL TTW7807 Acumen Medical, Inc. | DYB |
| Oct 15, 2004 | K041506 | INTRAVASCULAR ACCESS INTRODUCER SHEATH Applied Medical Resources Corp. | DYB |
| Aug 23, 2004 | K042036 | AIRGUARD VALVED INTRODUCER C.R. Bard, Inc. | DYB |
| Jun 18, 2004 | K040728 | ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT AngioDynamics, Inc. | DYB |
| Jun 1, 2004 | K040713 | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM Thomas Medical Products, Inc. | DYB |
| May 28, 2004 | K040552 | MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 Cryocor, Inc. | DYB |
| Apr 5, 2004 | K040029 | SAFETYNET GUIDEWIRE INTRODUCER Injectimed, Inc. | DYB |
| Mar 26, 2004 | K034025 | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC Nmt Medical, Inc. | DYB |
| Feb 18, 2004 | K040150 | MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER Medamicus, Inc. | DYB |
| Feb 5, 2004 | K033527 | INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER B.Braun Medical, Inc. | DYB |
| Jan 30, 2004 | K034061 | MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH Boston Scientific Corp | DYB |
| Dec 11, 2003 | K033681 | GLIDESHEATH Terumo Corp. | DYB |
| Oct 1, 2003 | K031922 | CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W Merit Medical Systems, Inc. | DYB |
| Sep 16, 2003 | K032569 | SHORT INTRODUCER SHEATH Rex Medical | DYB |
| Sep 10, 2003 | K032404 | SELDINGER SAFETY NEEDLE INTRODUCER Hdc Corp. | DYB |
| Sep 10, 2003 | K030734 | PATHWAY ACCESS SHEATH CATHETER Vertelink Corporation | DYB |
| Aug 13, 2003 | K032073 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. Gore & Associates, Inc. | DYB |
| Jul 18, 2003 | K031906 | APEEL CS CATHETER DELIVERY SYSTEM St Jude Medical | DYB |
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