510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844045Substantially Equivalent

Advanced Cardiovascular Systems Angioject

Advanced Cardiovascular Systems, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844045 is the FDA 510(k) clearance record for ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT, a class II device, cleared for Advanced Cardiovascular Systems, Inc. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show no recalls naming K844045.

Clearance record

Decision date
Received
(27 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Advanced Cardiovascular Systems, Inc. 1500 Salado Dr., Suite 101, Mountain View CA
Third party review
No

Clearances, product code DXT

Trailing 12 months
7 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 20261