The following data is part of a premarket notification filed by Cardiovascular Dynamics, Inc. with the FDA for Cvd Bullett Hi-flo Infusion Catheter.
| Device ID | K951503 |
| 510k Number | K951503 |
| Device Name: | CVD BULLETT HI-FLO INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | CARDIOVASCULAR DYNAMICS, INC. 15 HAMMOND SUITE 307 Irvine, CA 92718 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-28 |
| Decision Date | 1995-05-04 |