TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
FDA 510(k) clearance K133157 · decided 2014-10-23
Clearance details
- K-number
- K133157
- Device name
- TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-17
- Decision date
- 2014-10-23
- Days to decision
- 371 days
- Clearance type
- Traditional
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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