Kensey Nash Corp.
Medical device manufacturer in Exton, PA.
25510(k) clearances
0PMA approvals
8recalls
Device types
- FTM Mesh, Surgical 6
- NFA Temporary Coronary Saphenous Vein Bypass… 3
- MQV Filler, Bone Void, Calcium Compound 3
- NPL Barrier, Animal Source, Intraoral 3
- GCJ Laparoscope, General & Plastic Surgery 2
- QEZ Aspiration Thrombectomy Catheter 2
- MCW Catheter, Peripheral, Atherectomy 2
- LZN Cement Obturator 1
- FTL Mesh, Surgical, Polymeric 1
- DQX Wire, Guide, Catheter 1
- KGN Wound Dressing With Animal-Derived… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K121310 | Mesothelium Dental MembraneNPL · Traditional | 07/11/2013SE |
| K112888 | Meso Wound MatrixKGN · Traditional | 02/10/2012SE |
| K103787 | Medeor MatrixFTM · Traditional | 02/07/2011SE |
| K094061 | Kensey Nash Ecm Surgical PatchFTM · Traditional | 05/18/2010SE |
| K091192 | Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XXNPL · Traditional | 11/02/2009SE |
| K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)FTM · Traditional | 10/22/2009SE |
| K090919 | Kensey Nash Fibrillar Collagen Dental MembraneNPL · Traditional | 10/02/2009SE |
| K073519 | Quickcat Extraction Catheter, Model 60090-01QEZ · Special | 03/28/2008SE |
| K073162 | Safe-Cross(R) Radio Frequency Total Occlusion Crossing System, Safe-Cross(R) Radio…DQX · Special | 02/08/2008SE |
| K071695 | Kensey Nash Macropore ShieldFTL · Traditional | 12/31/2007SE |
| K072384 | Modification to Copios Bone Void Filler Sponge & PasteMQV · Special | 09/21/2007SE |
| K072195 | Thromcat Thrombectomy Catheter SystemMCW · Special | 08/23/2007SE |
| K071237 | Copios Bone Void Filler Sponge and PasteMQV · Special | 06/01/2007SE |
| K062870 | Triactiv FX Embolic Protection System, Model PN 60040-02; -03NFA · Special | 10/20/2006SE |
| K060917 | Kensey Nash Bone Void FillerMQV · Traditional | 09/22/2006SE |
| K061772 | Triactiv FX Embolic Protection SystemNFA · Traditional | 07/11/2006SE |
| K061030 | Bioblanket Surgical MeshFTM · Special | 05/09/2006SE |
| K060016 | Thromcat Thrombectomy Catheter SystemMCW · Traditional | 04/25/2006SE |
| K060092 | Quickcat Extraction CatheterQEZ · Traditional | 03/09/2006SE |
| K043259 | Bioblanket Surgical MeshFTM · Traditional | 08/15/2005SE |
| K042040 | Triactiv SystemNFA · Traditional | 03/23/2005SE |
| K041923 | BioblanketFTM · Traditional | 09/08/2004SE |
| K011943 | Impro Vise Absorbable Cement Flow RestrictorLZN · Traditional | 09/19/2001SE |
| K926089 | Kensey Nash Wuik-Sert(Tm) Endoscopic Surg GrasperGCJ · Traditional | 07/23/1993SE |
| K923726 | Kensey Nash Dynamic Clip SystemGCJ · Traditional | 04/06/1993SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1623-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the… | 02/28/2012Terminated |
| Z-1622-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the… | 02/28/2012Terminated |
| Z-1621-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the… | 02/28/2012Terminated |
| Z-1115-2007 | ThromCat Thrombectomy Catheter System. Catalog number 63000-01Defective component (power supply) | 05/21/2007Terminated |
| Z-0835-2007 | ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product…Insufficient wire sealing | 03/28/2007Terminated |
| Z-0834-2007 | FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is…Insufficient wire sealing | 03/28/2007Terminated |
| Z-0833-2007 | TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm…Insufficient wire sealing | 03/28/2007Terminated |
| Z-0597-2007 | ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01.…Face seal may wear excessively and cause particulate matter. | 02/07/2007Terminated |