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510(k) K961137

ATI PLASMA PUMP (PP-04) by Apheresis Technologies, Inc. — Product Code FIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1996
Date Received
March 21, 1996
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 Apheresis Technologies, Inc.

  • K926409 — PLASMA DISCARD BAGS (March 2, 1993)

Other clearances for product code FIR

  • K831953 — INFUSION PUMP (July 19, 1983)
  • 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)