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FDA 510(k)

QUART ARTERIAL FILTER WITH BIOLINE COATING

K-Number: K082544 · 2008-10-03

ApplicantMaquet Cardiopulmonary, AG
Decision Date2008-10-03
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUART ARTERIAL FILTER WITH BIOLINE 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 2008-10-03 under 510(k) number K082544. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUART ARTERIAL FILTER WITH BIOLINE COATING?

QUART ARTERIAL FILTER WITH BIOLINE COATING is a medical device that received FDA 510(k) clearance on 2008-10-03. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K082544.

When did QUART ARTERIAL FILTER WITH BIOLINE COATING receive FDA 510(k) clearance?

QUART ARTERIAL FILTER WITH BIOLINE COATING received FDA 510(k) clearance on 2008-10-03, under 510(k) number K082544.

Who is the listed applicant for QUART ARTERIAL FILTER WITH BIOLINE 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 QUART ARTERIAL FILTER WITH BIOLINE COATING?

The FDA product code for QUART ARTERIAL FILTER WITH BIOLINE COATING is DTM.

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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: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.

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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