The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Itc Bunji Platinum Embolization Coil.
| Device ID | K925523 |
| 510k Number | K925523 |
| Device Name: | ITC BUNJI PLATINUM EMBOLIZATION COIL |
| Classification | Device, Neurovascular Embolization |
| 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 | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-03-23 |