The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Thromcat Thrombectomy Catheter System.
| Device ID | K060016 |
| 510k Number | K060016 |
| Device Name: | THROMCAT THROMBECTOMY CATHETER SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA AVE. Exton, PA 19341 |
| Contact | Jennifer J Bosley |
| Correspondent | Jennifer J Bosley KENSEY NASH CORP. 735 PENNSYLVANIA AVE. Exton, PA 19341 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-03 |
| Decision Date | 2006-04-25 |
| Summary: | summary |