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510(k) K971015

AHCS HEMOPERFUSION SYSTEM by American Health Care Systems, Inc. — Product Code FLD

K971015 is an FDA 510(k) premarket notification submitted by American Health Care Systems, Inc. for the device "AHCS HEMOPERFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 1997. The device falls under product code FLD (Apparatus, Hemoperfusion, Sorbent), a Class II device regulated under 21 CFR 876.5870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1997
Date Received
March 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Hemoperfusion, Sorbent
Device Class
Class II
Regulation Number
876.5870
Review Panel
GU
Submission Type

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  • K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS) (December 14, 2012)
  • K033262 — MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) (May 27, 2005)
  • K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) (September 10, 1999)
  • K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000- (August 13, 1999)
  • K953751 — BIOLOGIC-DT SYSTEM (February 15, 1996)
  • K885017 — HEMOSORBA CH-500, CH-350 AND CH-180 (March 17, 1989)
  • K873643 — GAMBRO ADSORBA 150C (December 29, 1987)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K831029 — HEMOPERFUSION SYSTEM TP-400 (August 26, 1983)

FDA data resources