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510(k) K090698

CAPIOX BUBBLE TRAP WITH X-COATING by Terumo Cardiovascular Systems — Product Code KRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2009
Date Received
March 17, 2009
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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Other clearances for product code KRL

  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K071231 — EDAC QUANTIFIER (May 17, 2007)
  • K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC) (October 31, 1996)
  • K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM (October 29, 1996)
  • 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)
  • K864619 — CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (February 3, 1987)