510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000013Substantially Equivalent

Acist Angiographic Injection System, Model R-2000

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

K000013 is the FDA 510(k) clearance record for ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000, a class II device, cleared for Acist Medical Systems on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list 24 510(k) clearances for Acist Medical Systems, from to . As of , FDA records show no recalls naming K000013.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Acist Medical Systems 7450 Flying Clouds Dr., Eden Prairie MN
510(k) summary
Summary
Third party review
No

Clearances, product code DXT

Trailing 12 months
6 clearances under product code DXT in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260