DeviceClearance

ACIST RXi System and Navvus II Catheter— 510(k) K190473

Substantially Equivalent

Acist 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..

Clearance details

Applicant
Acist Medical Systems, Inc.
Product code
Code OBI
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eden Prairie, MN, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.