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510(k) K823272

VENOUS RESERVOIR BAG #BMR-1400 by Bentley Laboratories, Inc. — Product Code DTN

K823272 is an FDA 510(k) premarket notification submitted by Bentley Laboratories, Inc. for the device "VENOUS RESERVOIR BAG #BMR-1400". The FDA issued a decision of Substantially Equivalent on December 30, 1982. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Bentley Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
November 2, 1982
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 Bentley Laboratories, Inc.

  • K931967 — HE-30 GOLD (July 13, 1993)
  • K913956 — BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 (January 17, 1992)
  • K913692 — VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) (November 15, 1991)
  • K903641 — QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q (November 9, 1990)
  • K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (February 28, 1990)
  • K874867 — CATR(TM)-H CARDIOTOMY HOLDER (February 2, 1988)
  • K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (February 2, 1988)
  • K874618 — BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER (January 19, 1988)
  • K823273 — BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. (January 5, 1983)
  • K823359 — OXYGEN CONSUMPTION MONITOR #OCM-0100 (January 5, 1983)

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