The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Detachable Silicone Balloon (dsb).
| Device ID | K964488 |
| 510k Number | K964488 |
| Device Name: | DETACHABLE SILICONE BALLOON (DSB) |
| Classification | Balloon, Detachable, For Neurovascular Occlusion |
| Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW DR. Freemont, CA 94538 -6530 |
| Contact | Lynn K Bell |
| Correspondent | Lynn K Bell TARGET THERAPEUTICS 47201 LAKEVIEW DR. Freemont, CA 94538 -6530 |
| Product Code | MZQ |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-08 |
| Decision Date | 1998-04-21 |
| Summary: | summary |