The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Itc Coaxial Angiographic Cath Set, Modification.
| Device ID | K912477 |
| 510k Number | K912477 |
| Device Name: | ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | INTERVENTIONAL THERAPEUTICS CORP. 385 OYSTER POINT BLVD. SUITE 6 South San Francisco, CA 94080 |
| Contact | Luanne Termeer |
| Correspondent | Luanne Termeer INTERVENTIONAL THERAPEUTICS CORP. 385 OYSTER POINT BLVD. SUITE 6 South San Francisco, CA 94080 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1991-11-05 |