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510(k) K140321

INITARY BETTER BLADDER-PEDIATRIC by Circulatory Technology, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2014
Date Received
February 18, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by Circulatory Technology, Inc.

  • K012942 — THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, C (November 5, 2001)
  • K001822 — THE V-BAG (July 7, 2000)
  • K981284 — BETTER-BLADDER (BB) (August 12, 1998)
  • K964205 — BETTER-TUBING (April 8, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K961594 — BETTER-VENTER (September 5, 1996)
  • K941492 — PRESSURE RELIEF VALVE (October 26, 1994)
  • K942933 — PRESSURE INFUSION CUFF (August 25, 1994)

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