WIRION
FDA 510(k) clearance K200198 · decided 2020-03-18
Clearance details
- K-number
- K200198
- Device name
- WIRION
- Applicant
- Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-27
- Decision date
- 2020-03-18
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St.Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.