510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193183Substantially Equivalent

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

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

K193183 is the FDA 510(k) clearance record for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter, a class II device, cleared for Acist Medical Systems, Inc. on under FDA product code OBJ (Catheter, Ultrasound, Intravascular). FDA's definition for product code OBJ reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". FDA records list 24 510(k) clearances for Acist Medical Systems, Inc., from to . As of , FDA records show one recall naming K193183.

Clearance record

Decision date
Received
(123 days to decision)
Product code
OBJ Catheter, Ultrasound, Intravascular
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 OBJ

Trailing 12 months
4 clearances under product code OBJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OBJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260