Home / 510(k) Clearances / K911632

510(k) K911632

CAPIOX(R) BUBBLE TRAP by Terumo Medical Corp. — Product Code KRL

K911632 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "CAPIOX(R) BUBBLE TRAP". The FDA issued a decision of Substantially Equivalent on July 9, 1991. The device falls under product code KRL (Detector, Bubble, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4205. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1991
Date Received
April 11, 1991
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

Other clearances by Terumo Medical Corp.

  • K111606 — PINNACLE PRECISION ACCESS SYSTEM (October 3, 2011)
  • K111556 — GLIDECROSS SUPPORT CATHETER (July 29, 2011)
  • K110540 — TERUMO SUPPORT CATHETER (May 13, 2011)
  • K102008 — GLIDESHEATH (July 21, 2010)
  • K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (May 29, 2009)
  • K082997 — TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER (April 15, 2009)
  • K090040 — RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) (February 6, 2009)
  • K082847 — PINNACLE ROII INTRODUCER SHEATH (October 29, 2008)
  • K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER (September 26, 2008)
  • K082736 — RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (September 24, 2008)

Other clearances for product code KRL

  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K090698 — CAPIOX BUBBLE TRAP WITH X-COATING (June 8, 2009)
  • 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)
  • K864619 — CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (February 3, 1987)

FDA data resources