Pantheris System
FDA 510(k) clearance K212047 · decided 2021-11-16
Clearance details
- K-number
- K212047
- Device name
- Pantheris System
- Applicant
- Avinger, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-30
- Decision date
- 2021-11-16
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.