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FDA 510(k)

SHILEY ARTERIAL FILTER W/40 MICRON SCREE

K-Number: K812742 · 1981-11-02

ApplicantShiley, Inc.
Decision Date1981-11-02
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY ARTERIAL FILTER W/40 MICRON SCREE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812742. 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 SHILEY ARTERIAL FILTER W/40 MICRON SCREE?

SHILEY ARTERIAL FILTER W/40 MICRON SCREE is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Shiley, Inc.. The 510(k) number is K812742.

When did SHILEY ARTERIAL FILTER W/40 MICRON SCREE receive FDA 510(k) clearance?

SHILEY ARTERIAL FILTER W/40 MICRON SCREE received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812742.

Who is the listed applicant for SHILEY ARTERIAL FILTER W/40 MICRON SCREE?

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

What is the FDA product code for SHILEY ARTERIAL FILTER W/40 MICRON SCREE?

The FDA product code for SHILEY ARTERIAL FILTER W/40 MICRON SCREE is DTM.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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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