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510(k) K831029

HEMOPERFUSION SYSTEM TP-400 by Extracorporeal Medical Specialities, Inc. — Product Code FLD

K831029 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "HEMOPERFUSION SYSTEM TP-400". The FDA issued a decision of Substantially Equivalent on August 26, 1983. The device falls under product code FLD (Apparatus, Hemoperfusion, Sorbent), a Class II device regulated under 21 CFR 876.5870. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1983
Date Received
March 30, 1983
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 Extracorporeal Medical Specialities, Inc.

  • K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (November 29, 1984)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (May 30, 1984)
  • K840146 — EXP* 700 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K840057 — EXP* 500 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K832547 — ULTRAFILTRATION CONTROLLER (January 3, 1984)
  • K831423 — THERAPEUTIC EXCHANGE SYSTEM (January 3, 1984)
  • K833477 — INTERSEPT 40 MICRON FILTER (December 27, 1983)
  • K833476 — INTERSEPT 40 MICRON FILTER W/TUBING (December 27, 1983)
  • K831424 — THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (October 14, 1983)

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)
  • 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)

FDA data resources