ACIST RXi System and Navvus II Catheter— 510(k) K190473
Substantially EquivalentAcist Medical Systems, Inc.
FDA 510(k) clearance K190473 for ACIST RXi System and Navvus II Catheter, Substantially Equivalent on 2019-09-13. Applicant: Acist Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Acist Medical Systems, Inc.
- Product code
- Code OBI
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.