The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Catheter, Balloon Type.
| Device ID | K950398 |
| 510k Number | K950398 |
| Device Name: | CATHETER, BALLOON TYPE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | INTERVENTIONAL THERAPEUTICS CORP. 48668 MILMONT DR. Fremont, CA 94538 |
| Contact | Lynn K Bell |
| Correspondent | Lynn K Bell INTERVENTIONAL THERAPEUTICS CORP. 48668 MILMONT DR. Fremont, CA 94538 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-01 |
| Decision Date | 1995-10-05 |