510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190473Substantially Equivalent

ACIST RXi System and Navvus II Catheter

Acist Medical Systems, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190473 is the FDA 510(k) clearance record for ACIST RXi System and Navvus II Catheter, a class II device, cleared for Acist Medical Systems, Inc. on under FDA product code OBI (Catheter, Pressure Monitoring, Cardiac). FDA's definition for product code OBI reads: "To measure pressure within the cardiovascular system". FDA records list 24 510(k) clearances for Acist Medical Systems, Inc., from to . As of , FDA records show no recalls naming K190473.

Clearance record

Decision date
Received
(198 days to decision)
Product code
OBI Catheter, Pressure Monitoring, Cardiac
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Acist Medical Systems, Inc. 7905 Fuller Rd., Eden Prairie MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBI

Trailing 12 months

FDA records hold no clearances under product code OBI in the trailing twelve months.

FDA records show no clearances under product code OBI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260