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510(k) K821139

SPS-SINGLE PATIENT SYSTEM by Extracorporeal Medical Specialities, Inc. — Product Code FIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1982
Date Received
April 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Extra-Luminal
Device Class
Class II
Regulation Number
876.5820
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)
  • K840057 — EXP* 500 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K840146 — EXP* 700 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K831423 — THERAPEUTIC EXCHANGE SYSTEM (January 3, 1984)
  • K832547 — ULTRAFILTRATION CONTROLLER (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 FIR

  • K961137 — ATI PLASMA PUMP (PP-04) (June 14, 1996)
  • K831953 — INFUSION PUMP (July 19, 1983)
  • K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A & (April 12, 1983)
  • K780410 — BLOOD PUMP-MODE S10K (May 3, 1978)
  • K771705 — RS-7800 MINIPUMP (October 4, 1977)
  • K761050 — HEPARIN PUMP (December 30, 1976)