SHORT TEGWIRE -- MODIFIED
FDA 510(k) clearance K924276 · decided 1992-11-10
Clearance details
- K-number
- K924276
- Device name
- SHORT TEGWIRE -- MODIFIED
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1992-08-13
- Decision date
- 1992-11-10
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.