YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
FDA 510(k) clearance K171653 · decided 2017-07-03
Clearance details
- K-number
- K171653
- Device name
- YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-05
- Decision date
- 2017-07-03
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.