The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Occlusion Ballon Catheter Modificaion.
| Device ID | K921399 |
| 510k Number | K921399 |
| Device Name: | OCCLUSION BALLON CATHETER MODIFICAION |
| Classification | Clamp, Vascular |
| 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 | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-09-25 |