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510(k) K012942

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 by Circulatory Technology, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2001
Date Received
August 31, 2001
Clearance Type
Traditional
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.

  • K140321 — INITARY BETTER BLADDER-PEDIATRIC (April 17, 2014)
  • 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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  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSU (June 12, 2014)