The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Miller Percutaneous Angiographic/scopic Irri. Cath.
| Device ID | K897051 |
| 510k Number | K897051 |
| Device Name: | MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CATHLAB CORP. 2695 DOW AVE. Tustin, CA 92680 |
| Contact | Daniel R Lucas |
| Correspondent | Daniel R Lucas CATHLAB CORP. 2695 DOW AVE. Tustin, CA 92680 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-16 |