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FDA 510(k)

VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING

K-Number: K090690 · 2009-12-23

ApplicantMaquet Cardiopulmonary, AG
Decision Date2009-12-23
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING 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 2009-12-23 under 510(k) number K090690. 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 SOFTBAG RESERVOIRS WITH SOFTLINE COATING?

VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K090690.

When did VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING receive FDA 510(k) clearance?

VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING received FDA 510(k) clearance on 2009-12-23, under 510(k) number K090690.

Who is the listed applicant for VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING?

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 SOFTBAG RESERVOIRS WITH SOFTLINE COATING?

The FDA product code for VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING is DTN.

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Other records listing Maquet Cardiopulmonary, AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133265QUADROX-IR ADULT AND SMALL ADULTK132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTK132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSK131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGK130300HEATER-COOLER UNIT HCU 40K123288HEMOCONCENTRATOR

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Related Devices (Code: DTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 SurgeryK223361BMR 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.

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