The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Quickcat Extraction Catheter.
| Device ID | K060092 |
| 510k Number | K060092 |
| Device Name: | QUICKCAT EXTRACTION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA AVE. Exton, PA 19341 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson KENSEY NASH CORP. 735 PENNSYLVANIA AVE. Exton, PA 19341 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-12 |
| Decision Date | 2006-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2046009001AA0 | K060092 | 000 |