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510(k) K803102

ARTERIAL BUBBLE TRAP K-20 by Delta Medical Industries — Product Code KRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
December 9, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Bubble, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4205
Review Panel
CV
Submission Type

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  • 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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  • K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC) (October 31, 1996)
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  • K940651 — SARNS ULTRASONIC AIR SENSOR (May 24, 1994)
  • K935977 — SARNS AIR DETECTION SYSTEM (February 4, 1994)
  • K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (May 18, 1993)
  • K925541 — STOCKERT 1/4 BUBBLE SENSOR (February 2, 1993)
  • K911632 — CAPIOX(R) BUBBLE TRAP (July 9, 1991)