ACIST RXi System and Navvus II Catheter
FDA 510(k) K190473 · Acist Medical Systems, Inc.
510(k) numberK190473
Submission
- Device name
- ACIST RXi System and Navvus II Catheter
- Applicant
- Acist Medical Systems, Inc.
Eden Prairie, MN, US - Received
- February 27, 2019
- Decision date
- September 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBI – Catheter, Pressure Monitoring, Cardiac
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
To measure pressure within the cardiovascular system.
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Questions and answers
When was ACIST RXi System and Navvus II Catheter cleared by the FDA?
ACIST RXi System and Navvus II Catheter (K190473) received a 510(k) decision of Substantially Equivalent on September 13, 2019, 198 days after the submission was received.
What is the product code of K190473?
The FDA product code is OBI – Catheter, Pressure Monitoring, Cardiac, a Class II (moderate risk) device regulated under 21 CFR 870.1200.