The following data is part of a premarket notification filed by Applied Vascular with the FDA for Diagnostic Intravascular Catheter.
| Device ID | K923699 |
| 510k Number | K923699 |
| Device Name: | DIAGNOSTIC INTRAVASCULAR CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | APPLIED VASCULAR 26051 MERIT CIRCLE BUILDING 104 Launa Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED VASCULAR 26051 MERIT CIRCLE BUILDING 104 Launa 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 | 1992-07-24 |
| Decision Date | 1992-12-21 |