The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Intherm Temporary Occlusion Catheter.
| Device ID | K901287 |
| 510k Number | K901287 |
| Device Name: | INTHERM TEMPORARY OCCLUSION CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | INTERVENTIONAL THERAPEUTICS CORP. 2665 MARINE WAY Mountain View, CA 94043 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols INTERVENTIONAL THERAPEUTICS CORP. 2665 MARINE WAY Mountain View, CA 94043 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1991-02-20 |