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510(k) K801770

ARTERIAL BUBBLE TRAP by Delta Medical Industries — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
July 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Delta Medical Industries

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  • K830389 — ACCU-RYNGE PUMP SP-250 (September 12, 1983)
  • K831750 — PM-3 (July 26, 1983)
  • K822761 — DELIVERY TUBE SET #2226 (September 30, 1982)
  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)
  • K820482 — ACCU-RYNGE INSULIN PUMP #SP-250 (March 26, 1982)
  • K810068 — PEDIATRIC ARTERIAL BLOOD FILTER (January 22, 1981)
  • K802755 — ARTERIAL BLOOD FILTER BF-37 (January 7, 1981)

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