The following data is part of a premarket notification filed by Cardiovascular Dynamics, Inc. with the FDA for Cvd Bullett Peripheral Infusion Catheter.
| Device ID | K943023 |
| 510k Number | K943023 |
| Device Name: | CVD BULLETT PERIPHERAL INFUSION CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CARDIOVASCULAR DYNAMICS, INC. 13844 ALTON PKWY. SUITE 140 Irvine, CA 92718 |
| Contact | Michael Crocker |
| Correspondent | Michael Crocker CARDIOVASCULAR DYNAMICS, INC. 13844 ALTON PKWY. SUITE 140 Irvine, CA 92718 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-24 |
| Decision Date | 1994-09-30 |