510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841992Substantially Equivalent

Modification to Acs Coronary Guiding

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

K841992 is the FDA 510(k) clearance record for MODIFICATION TO ACS CORONARY GUIDING, a class II device, cleared for Advanced Cardiovascular Systems, Inc. on under FDA product code DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control). FDA records list 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show no recalls naming K841992.

Clearance record

Decision date
Received
(47 days to decision)
Product code
DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Advanced Cardiovascular Systems, Inc. 3200 Lakeside Dr., Santa Clara CA
Third party review
No

Clearances, product code DAO

Trailing 12 months

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

FDA records show no clearances under product code DAO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DAO, 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