The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Opti-flow & Opti-torque Angiographic Catheters.
| Device ID | K844800 |
| 510k Number | K844800 |
| Device Name: | OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Contact | Kamal Kalwani |
| Correspondent | Kamal Kalwani VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-11 |
| Decision Date | 1985-05-16 |