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 1, 2010 | K093877 | RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 Edwards Lifesciences, LLC | DYB |
| Jun 17, 2010 | K101399 | COAXIAL INTRODUCER SET Martech Medical Products | DYB |
| May 6, 2010 | K092097 | A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH A.B. Korkor Medical, Inc. | DYB |
| Mar 30, 2010 | K100615 | ARSTASIS ACCESS SYSTEM Arstasis, Inc. | DYB |
| Mar 22, 2010 | K093791 | GORE DRYSEAL SHEATH W. L. Gore & Associates, Inc. | DYB |
| Mar 15, 2010 | K093232 | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER Great Batch Medical | DYB |
| Feb 25, 2010 | K091006 | ITG VASCULAR ACCESS SYSTEM, MODEL 300 Arstasis, Inc. | DYB |
| Feb 24, 2010 | K093026 | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER Footprint Medical | DYB |
| Jan 20, 2010 | K093022 | THE PICC WAND PEELABLE SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Jan 8, 2010 | K091954 | MICRO-STICK SET Medcomp | DYB |
| Nov 5, 2009 | K091367 | GDS-DCS Guided Delivery Systems | DYB |
| Nov 4, 2009 | K093130 | ENGAGE TR INTRODUCER St Jude Medical | DYB |
| Oct 29, 2009 | K093023 | PTFE PEELABLE INTRODUCER Great Batch Medical | DYB |
| Oct 8, 2009 | K092575 | ENGAGE/ENGAGE TR St Jude Medical | DYB |
| Oct 8, 2009 | K092014 | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER Onset Medical Corporation | DYB |
| Sep 1, 2009 | K090394 | VALVED TEARWAY INTRODUCER Medcomp | DYB |
| Jul 30, 2009 | K090867 | AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 Ep Dynamics, Inc. | DYB |
| Jun 4, 2009 | K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S Oscor, Inc. | DYB |
| May 29, 2009 | K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Apr 22, 2009 | K091137 | ULTIMUM/ENGAGE/ENGAGE TR St Jude Medical | DYB |
| Apr 15, 2009 | K090999 | BIOCARDIA MORPH SHEATH GUIDE Biocardia, Inc. | DYB |
| Mar 30, 2009 | K090372 | THE WAND MICROACCESS SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Feb 17, 2009 | K083855 | MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 Acumen Medical, Inc. | DYB |
| Feb 3, 2009 | K083269 | CROSSOVER Thomas Medical Products, Inc. | DYB |
| Dec 15, 2008 | K083402 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 St Jude Medical | DYB |
| Dec 9, 2008 | K081645 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 St Jude Medical | DYB |
| Dec 8, 2008 | K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE Spectra Medical Devices, Inc. | DYB |
| Dec 4, 2008 | K081697 | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 Access Scientific, Inc. | DYB |
| Nov 6, 2008 | K083083 | AGILIS NXT STEERABLE INTRODUCER St Jude Medical | DYB |
| Oct 29, 2008 | K082847 | PINNACLE ROII INTRODUCER SHEATH Terumo Medical Corp. | DYB |
| Oct 15, 2008 | K082063 | PRELUDE SHORT SHEATH INTRODUCER Merit Medical Systems, Inc. | DYB |
| Sep 18, 2008 | K082644 | GLIDESHEATH Terumo Medical Corp. | DYB |
| Sep 15, 2008 | K081394 | PTFE INTERLOCK PEELABLE INTRODUCERS Enpath Medical, Inc. | DYB |
| Aug 28, 2008 | K082356 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. Gore & Associates, Inc. | DYB |
| May 28, 2008 | K081045 | DESTINATION RENAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| May 21, 2008 | K081046 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| May 14, 2008 | K081341 | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) Thomas Medical Products, Inc. | DYB |
| Apr 1, 2008 | K073434 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. | DYB |
| Mar 13, 2008 | K080500 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 Acumen Medical, Inc. | DYB |
| Mar 7, 2008 | K080415 | DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Mar 7, 2008 | K072719 | CONVOY ADVANCED DELIVERY SHEATH Boston Scientific Corp | DYB |
| Nov 30, 2007 | K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S Oscor, Inc. | DYB |
| Nov 9, 2007 | K072248 | VIAPEEL PEELABLE INTRODUCER Enpath Medical, Inc. | DYB |
| Oct 31, 2007 | K072130 | PTFE PEEL AWAY MICROINTRODUCER Intromed | DYB |
| Oct 23, 2007 | K070865 | EXPANDING VASCULAR SHEATH Applied Medical | DYB |
| Sep 19, 2007 | K070816 | PERIPHERAL GUIDING SHEATH Micrus Design Technology, Inc. | DYB |
| Sep 12, 2007 | K063658 | INTRAVASCULAR INTRODUCER SYSTEM Applied Medical Resources Corp. | DYB |
| Jul 5, 2007 | K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT Enpath Medical, Inc. | DYB |
| Jun 5, 2007 | K070417 | ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 St Jude Medical | DYB |
| May 22, 2007 | K070396 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 Acumen Medical, Inc. | DYB |
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