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510(k) K831953

INFUSION PUMP by Cryosan, Inc. — Product Code FIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 15, 1983
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 Cryosan, Inc.

  • K830831 — AUTOMATED BLOOD CELL SEPARATOR (June 16, 1983)
  • K822521 — AUTOMATED BLOOD CELL SEPARATOR (September 30, 1982)
  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K812311 — CIRCULATING CYTO-THERMS (September 16, 1981)
  • K812309 — CRYOSAN NORMAL SALINE (September 16, 1981)

Other clearances for product code FIR

  • K961137 — ATI PLASMA PUMP (PP-04) (June 14, 1996)
  • K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A & (April 12, 1983)
  • K821139 — SPS-SINGLE PATIENT SYSTEM (May 10, 1982)
  • K780410 — BLOOD PUMP-MODE S10K (May 3, 1978)
  • K771705 — RS-7800 MINIPUMP (October 4, 1977)
  • K761050 — HEPARIN PUMP (December 30, 1976)