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510(k) K935717

AFFINITY VENOUS RESERVIOR BAG by Avecor Cardiovascular, Inc. — Product Code DTN

K935717 is an FDA 510(k) premarket notification submitted by Avecor Cardiovascular, Inc. for the device "AFFINITY VENOUS RESERVIOR BAG". The FDA issued a decision of Substantially Equivalent on May 10, 1994. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Avecor Cardiovascular, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1994
Date Received
November 30, 1993
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 Avecor Cardiovascular, Inc.

  • K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE (February 18, 1998)
  • K964017 — AFFINITY BLOOD PUMP SYSTEM (August 5, 1997)
  • K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM (July 11, 1997)
  • K952532 — AFFINITY ARTERIAL BLOOD FILTER (October 6, 1995)
  • K940126 — AVECOR PRE-BYPASS FILTER (June 28, 1994)
  • K936003 — AFFINITY CVR (June 20, 1994)
  • K932252 — AFFINITY HOLLOW FIBER OXYGENATOR (November 19, 1993)
  • K924529 — SIGNATURE(TM) CUSTOM TUBING PACK (June 23, 1993)

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