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FDA 510(k)

HEPARINIZED ARTERIAL SCREEN BLOOD FILTER

K-Number: K900758 · 1990-05-17

ApplicantCobe Laboratories, Inc.
Decision Date1990-05-17
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEPARINIZED ARTERIAL SCREEN BLOOD FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1990-05-17 under 510(k) number K900758. 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 HEPARINIZED ARTERIAL SCREEN BLOOD FILTER?

HEPARINIZED ARTERIAL SCREEN BLOOD FILTER is a medical device that received FDA 510(k) clearance on 1990-05-17. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K900758.

When did HEPARINIZED ARTERIAL SCREEN BLOOD FILTER receive FDA 510(k) clearance?

HEPARINIZED ARTERIAL SCREEN BLOOD FILTER received FDA 510(k) clearance on 1990-05-17, under 510(k) number K900758.

Who is the listed applicant for HEPARINIZED ARTERIAL SCREEN BLOOD FILTER?

The FDA 510(k) record lists Cobe Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEPARINIZED ARTERIAL SCREEN BLOOD FILTER?

The FDA product code for HEPARINIZED ARTERIAL SCREEN BLOOD FILTER is DTM.

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Other records listing Cobe Laboratories, Inc. 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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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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