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FDA 510(k)

SHILEY PERFUSION TUBING SETS

K-Number: K920594 · 1993-03-18

ApplicantShiley, Inc.
Decision Date1993-03-18
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY PERFUSION TUBING SETS is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1993-03-18 under 510(k) number K920594. 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 PERFUSION TUBING SETS?

SHILEY PERFUSION TUBING SETS is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Shiley, Inc.. The 510(k) number is K920594.

When did SHILEY PERFUSION TUBING SETS receive FDA 510(k) clearance?

SHILEY PERFUSION TUBING SETS received FDA 510(k) clearance on 1993-03-18, under 510(k) number K920594.

Who is the listed applicant for SHILEY PERFUSION TUBING SETS?

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 PERFUSION TUBING SETS?

The FDA product code for SHILEY PERFUSION TUBING SETS 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.

K910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBEK901624SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.

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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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