510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971015Substantially Equivalent

Ahcs Hemoperfusion System

American Health Care Systems, Inc., Metairie LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971015 is the FDA 510(k) clearance record for AHCS HEMOPERFUSION SYSTEM, a class II device, cleared for American Health Care Systems, Inc. on under FDA product code FLD (Apparatus, Hemoperfusion, Sorbent). FDA records list one 510(k) clearance for American Health Care Systems, Inc. As of , FDA records show no recalls naming K971015.

Clearance record

Decision date
Received
(216 days to decision)
Product code
FLD Apparatus, Hemoperfusion, Sorbent
Regulation
21 CFR 876.5870
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Health Care Systems, Inc. 3350 Ridgelake Ave., Suite 255, Metairie LA
510(k) summary
Statement
Third party review
No

Clearances, product code FLD

Trailing 12 months

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

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