LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
FDA 510(k) clearance K152876 · decided 2016-01-08
Clearance details
- K-number
- K152876
- Device name
- LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
- Applicant
- Tni Manufacturing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-30
- Decision date
- 2016-01-08
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunrise, FL, 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.