510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864155Substantially Equivalent

Modification of Carpentier-Edwards Bioprosthesis

American Edwards Laboratories, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864155 is the FDA 510(k) clearance record for MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS, a class I device, cleared for American Edwards Laboratories on under FDA product code DTJ (Holder, Heart-Valve, Prosthesis). FDA records list 89 510(k) clearances for American Edwards Laboratories, from to . As of , FDA records show no recalls naming K864155.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DTJ Holder, Heart-Valve, Prosthesis
Regulation
21 CFR 870.3935
Device class
Class I
Review panel
Cardiovascular
Applicant
American Edwards Laboratories P.O. Box 11150, Santa Ana CA
Third party review
No

Clearances, product code DTJ

Trailing 12 months

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

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