DETACHABLE SILICONE BALLOON (DSB)
FDA 510(k) clearance K964488 · decided 1998-04-21
Clearance details
- K-number
- K964488
- Device name
- DETACHABLE SILICONE BALLOON (DSB)
- Applicant
- Target Therapeutics
- Decision
- Substantially Equivalent
- Date received
- 1996-11-08
- Decision date
- 1998-04-21
- Days to decision
- 529 days
- Clearance type
- Traditional
- Product code
- MZQ
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Freemont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DETACHABLE SLICONE BALLOON (DSB) (K965071) | Target Therapeutics | 1998-04-21 |
Recalls involving this device
No recalls on record reference this clearance.