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510(k) K830818

ASAHI BLOOD/PLASMA PUMP #ABP-01A & by Parker Hannifin Corp. — Product Code FIR

K830818 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corp. for the device "ASAHI BLOOD/PLASMA PUMP #ABP-01A &". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FIR (Pump, Blood, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. Parker Hannifin Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
March 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 Parker Hannifin Corp.

  • K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (April 22, 2021)
  • K161731 — Cleveland Multiport Ventricular Catheter Set (March 27, 2017)
  • K897086 — PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 (September 28, 1990)
  • K863532 — MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER (January 14, 1987)
  • K834461 — INFUSION PUMP PRIMER (January 30, 1984)
  • K833723 — MODEL 2000 AMBULATORY MED. INFUSER (January 30, 1984)
  • K831402 — PRESSURE MONITOR & CONTROL UNIT APC-02A (August 8, 1983)
  • K831747 — PLASMA THERAPY TUBESET-E100 SERIES (June 30, 1983)

Other clearances for product code FIR

  • K961137 — ATI PLASMA PUMP (PP-04) (June 14, 1996)
  • K831953 — INFUSION PUMP (July 19, 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)

FDA data resources