Company ยท US
Kensey Nash Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2013. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 7 |
| FTM | Mesh, Surgical | 6 |
| NPL | Barrier, Animal Source, Intraoral | 6 |
| MCW | Catheter, Peripheral, Atherectomy | 4 |
| FRO | Dressing, Wound, Drug | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| QEZ | Aspiration Thrombectomy Catheter | 2 |
| DQX | Wire, Guide, Catheter | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 |
| LZN | Cement Obturator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2013 | K121310 | MESOTHELIUM DENTAL MEMBRANE Kensey Nash Corporation | NPL |
| Feb 10, 2012 | K112888 | MESO WOUND MATRIX Kensey Nash Corporation | KGN |
| Feb 7, 2011 | K103787 | MEDEOR MATRIX Kensey Nash Corp. | FTM |
| May 18, 2010 | K094061 | KENSEY NASH ECM SURGICAL PATCH Kensey Nash Corporation | FTM |
| Nov 2, 2009 | K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX Kensey Nash Corp. | NPL |
| Oct 22, 2009 | K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) Kensey Nash Corp. | FTM |
| Oct 2, 2009 | K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE Kensey Nash Corp. | NPL |
| Mar 28, 2008 | K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 Kensey Nash Corp. | QEZ |
| Feb 8, 2008 | K073162 | SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING Kensey Nash Corporation | DQX |
| Dec 31, 2007 | K071695 | KENSEY NASH MACROPORE SHIELD Kensey Nash Corp. | FTL |
| Sep 21, 2007 | K072384 | MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE Kensey Nash Corp. | MQV |
| Aug 23, 2007 | K072195 | THROMCAT THROMBECTOMY CATHETER SYSTEM Kensey Nash Corp. | MCW |
| Jun 1, 2007 | K071237 | COPIOS BONE VOID FILLER SPONGE AND PASTE Kensey Nash Corp. | MQV |
| Oct 20, 2006 | K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 Kensey Nash Corp. | NFA |
| Sep 22, 2006 | K060917 | KENSEY NASH BONE VOID FILLER Kensey Nash Corporation | MQV |
| Jul 11, 2006 | K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM Kensey Nash Corp. | NFA |
| May 9, 2006 | K061030 | BIOBLANKET SURGICAL MESH Kensey Nash Corporation | FTM |
| Apr 25, 2006 | K060016 | THROMCAT THROMBECTOMY CATHETER SYSTEM Kensey Nash Corp. | MCW |
| Mar 9, 2006 | K060092 | QUICKCAT EXTRACTION CATHETER Kensey Nash Corp. | QEZ |
| Aug 15, 2005 | K043259 | BIOBLANKET SURGICAL MESH Kensey Nash Corp. | FTM |
| Mar 23, 2005 | K042040 | TRIACTIV SYSTEM Kensey Nash Corp. | NFA |
| Sep 8, 2004 | K041923 | BIOBLANKET Kensey Nash Corp. | FTM |
| Sep 19, 2001 | K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR Kensey Nash Corp. | LZN |
| Jul 23, 1993 | K926089 | KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER Kensey Nash Corp. | GCJ |
| Apr 6, 1993 | K923726 | KENSEY NASH DYNAMIC CLIP SYSTEM Kensey Nash Corp. | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2012 | Kensey Nash Corp a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2 Terminated |
NPL | K090919 |
| May 17, 2012 | Kensey Nash Corp a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2 Terminated |
NPL | K090919 |
| May 17, 2012 | Kensey Nash Corp a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2 Terminated |
NPL | K090919 |
| Jul 23, 2007 | Kensey Nash Corp ThromCat Thrombectomy Catheter System. Catalog number 63000-01 Terminated |
MCW | K060016 |
| May 31, 2007 | Kensey Nash Corp ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box. Terminated |
FRO | K061772 |
| May 31, 2007 | Kensey Nash Corp FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box. Terminated |
FRO | K061772 |
| May 31, 2007 | Kensey Nash Corp TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the Shie Terminated |
FRO | K061772 |
| Mar 8, 2007 | Kensey Nash Corp ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus Terminated |
MCW | K060016 |
| Jul 28, 2006 | Kensey Nash Corp TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach. Terminated |
NFA | None listed |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes. Terminated |
NFA | K042040 |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon Terminated |
NFA | K042040 |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon Terminated |
NFA | K042040 |