ACIST RXi System and Navvus II Catheter
FDA 510(k) clearance K190473 · decided 2019-09-13
Clearance details
- K-number
- K190473
- Device name
- ACIST RXi System and Navvus II Catheter
- Applicant
- Acist Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-27
- Decision date
- 2019-09-13
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- OBI
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.