TURBO-TANDEM SYSTEM MODEL 472-110
FDA 510(k) clearance K094036 · decided 2010-01-25
Clearance details
- K-number
- K094036
- Device name
- TURBO-TANDEM SYSTEM MODEL 472-110
- Applicant
- Spectranetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-30
- Decision date
- 2010-01-25
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Colorado Springs, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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