The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Mikro-tip Angiographic Catheter.
| Device ID | K993694 |
| 510k Number | K993694 |
| Device Name: | MIKRO-TIP ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MILLAR INSTRUMENTS, INC. 6001 GULF FREEWAY, #534-G Houston, TX 77023 -5417 |
| Contact | Mirielle Arce |
| Correspondent | Mirielle Arce MILLAR INSTRUMENTS, INC. 6001 GULF FREEWAY, #534-G Houston, TX 77023 -5417 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-02 |
| Decision Date | 2000-03-01 |