The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Diagnostic Intrascular Catheter.
| Device ID | K903848 |
| 510k Number | K903848 |
| Device Name: | DIAGNOSTIC INTRASCULAR CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1991-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663106882 | K903848 | 000 |
| 00840663106875 | K903848 | 000 |
| 00840663106868 | K903848 | 000 |