The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Occlusion Balloon Catheter.
| Device ID | K960832 |
| 510k Number | K960832 |
| Device Name: | OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| 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 | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-29 |
| Decision Date | 1996-05-29 |