M-CATH Microcatheter
FDA 510(k) clearance K171176 · decided 2017-09-15
Clearance details
- K-number
- K171176
- Device name
- M-CATH Microcatheter
- Applicant
- Acrostak (Schweiz) AG
- Decision
- Substantially Equivalent
- Date received
- 2017-04-21
- Decision date
- 2017-09-15
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Winterthur, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.