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510(k) K003551

VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 by Jostra AG — Product Code DTN

K003551 is an FDA 510(k) premarket notification submitted by Jostra AG for the device "VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201". The FDA issued a decision of Substantially Equivalent on July 11, 2001. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Jostra AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2001
Date Received
November 17, 2000
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 Jostra AG

  • K020983 — JOSTRA SUCKERS, MODEL JS (January 30, 2004)
  • K031544 — HEATER COOLER UNIT, MODEL HCU 30 (August 7, 2003)
  • K030264 — QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 (February 26, 2003)
  • K020784 — JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS (January 9, 2003)
  • K023132 — JOSTRA MECC SYSTEM (December 17, 2002)
  • K022022 — JOSTRA VENT CATHETERS, MODELS LV & HKV (September 11, 2002)
  • K020515 — JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (April 24, 2002)
  • K014303 — JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (March 26, 2002)
  • K013944 — JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (February 11, 2002)
  • K013939 — JOSTRA FLOWPROBE FP-32E (December 14, 2001)

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