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510(k) K953751

BIOLOGIC-DT SYSTEM by Hemocleanse, Inc. — Product Code FLD

K953751 is an FDA 510(k) premarket notification submitted by Hemocleanse, Inc. for the device "BIOLOGIC-DT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 15, 1996. 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
February 15, 1996
Date Received
August 10, 1995
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

Other clearances by Hemocleanse, Inc.

  • K993330 — THERMOCHEM-HT SYSTEM (December 30, 1999)
  • 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)
  • 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)
  • 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)
  • K971015 — AHCS HEMOPERFUSION SYSTEM (October 22, 1997)
  • 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