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510(k) K831423

THERAPEUTIC EXCHANGE SYSTEM by Extracorporeal Medical Specialities, Inc. — Product Code LQQ

K831423 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "THERAPEUTIC EXCHANGE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 1984. The device falls under product code LQQ (Columns, Immunoadsorption In Extracorporeal Systems), a Class III device. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
May 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Columns, Immunoadsorption In Extracorporeal Systems
Device Class
Class III
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Extracorporeal Medical Specialities, Inc.

  • K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (November 29, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (May 30, 1984)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840057 — EXP* 500 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K840146 — EXP* 700 PARALLEL PLATE DIALYZER (February 4, 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)
  • K832053 — SINGLE PATIENT SYS. II MODEL DM-450 (September 29, 1983)

FDA data resources