The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Prowler Select (10, 14, And Plus) Infusion Catheters With And Without Pre-shaped Tips.
| Device ID | K021591 |
| 510k Number | K021591 |
| Device Name: | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS |
| Classification | Catheter, Continuous Flush |
| Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Contact | Maritza Celaya |
| Correspondent | Maritza Celaya CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-15 |
| Decision Date | 2002-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704028895 | K021591 | 000 |
| 10886704028789 | K021591 | 000 |
| 10886704028796 | K021591 | 000 |
| 10886704028802 | K021591 | 000 |
| 10886704028819 | K021591 | 000 |
| 10886704028826 | K021591 | 000 |
| 10886704028840 | K021591 | 000 |
| 10886704028857 | K021591 | 000 |
| 10886704028864 | K021591 | 000 |
| 10886704028871 | K021591 | 000 |
| 10886704028888 | K021591 | 000 |
| 10886704028772 | K021591 | 000 |