510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900034Substantially Equivalent

Angio-Max

Accumed Systems, Inc., Shaker Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900034 is the FDA 510(k) clearance record for ANGIO-MAX, a class II device, cleared for Accumed Systems, Inc. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list one 510(k) clearance for Accumed Systems, Inc. As of , FDA records show no recalls naming K900034.

Clearance record

Decision date
Received
(140 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Accumed Systems, Inc. 14515 Drexmore Rd., Shaker Heights OH
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