FDA 510(k)

VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001

K-Number: K061743 · 2006-07-21

Decision Date2006-07-21

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiopulmonary, AG. It received FDA 510(k) clearance on 2006-07-21 under 510(k) number K061743. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001?

VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K061743.

When did VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 receive FDA 510(k) clearance?

VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 received FDA 510(k) clearance on 2006-07-21, under 510(k) number K061743.

Who is the listed applicant for VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001?

The FDA 510(k) record lists Maquet Cardiopulmonary, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001?

The FDA product code for VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 is DTN.

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Other records listing Maquet Cardiopulmonary, AG as applicant

K133265QUADROX-IR ADULT AND SMALL ADULT K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING K130300HEATER-COOLER UNIT HCU 40 K123288HEMOCONCENTRATOR

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Related Devices (Code: DTN)

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac Surgery K223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.