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510(k) K140321

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

K140321 is an FDA 510(k) premarket notification submitted by Circulatory Technology, Inc. for the device "INITARY BETTER BLADDER-PEDIATRIC". The FDA issued a decision of Substantially Equivalent on April 17, 2014. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Circulatory Technology, Inc. has at least 8 other 510(k) clearances on record.

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)

Other clearances for product code DTN

  • K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs (December 22, 2025)
  • K241206 — Quantum Perfusion Hybrid System (July 18, 2024)
  • K241053 — MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous (May 15, 2024)
  • K223361 — BMR 1900 PHISIO (June 10, 2023)
  • K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (March 17, 2017)
  • K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (March 8, 2017)
  • K153143 — Capiox Advance Hardshell Reservoir (December 2, 2015)
  • K151110 — Intersept Filtered Cardiotomy Reservoir (May 27, 2015)
  • 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)

FDA data resources