The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Irrigation Catheter 4, 6 And 10 French.
| Device ID | K902256 |
| 510k Number | K902256 |
| Device Name: | IRRIGATION CATHETER 4, 6 AND 10 FRENCH |
| Classification | Catheter, Percutaneous |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Robert P Cooper |
| Correspondent | Robert P Cooper APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1991-02-15 |