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510(k) K992196

BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) by Hemocleanse, Inc. — Product Code FLD

K992196 is an FDA 510(k) premarket notification submitted by Hemocleanse, Inc. for the device "BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)". The FDA issued a decision of Substantially Equivalent on September 10, 1999. The device falls under product code FLD (Apparatus, Hemoperfusion, Sorbent), a Class II device regulated under 21 CFR 876.5870. Hemocleanse, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1999
Date Received
June 30, 1999
Clearance Type
Special
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

Other clearances by Hemocleanse, Inc.

  • K993330 — THERMOCHEM-HT SYSTEM (December 30, 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)
  • K923046 — BIOLOGIC DT-1000 MACHINE (September 30, 1994)

Other clearances for product code FLD

  • K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONT (March 26, 2014)
  • K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS) (December 14, 2012)
  • K033262 — MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) (May 27, 2005)
  • K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000- (August 13, 1999)
  • K971015 — AHCS HEMOPERFUSION SYSTEM (October 22, 1997)
  • 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