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FDA 510(k)

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.

K-Number: K901624 · 1990-07-03

ApplicantShiley, Inc.
Decision Date1990-07-03
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K901624. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.?

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Shiley, Inc.. The 510(k) number is K901624.

When did SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. receive FDA 510(k) clearance?

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. received FDA 510(k) clearance on 1990-07-03, under 510(k) number K901624.

Who is the listed applicant for SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.?

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 PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.?

The FDA product code for SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. is DTZ.

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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: DTZ)

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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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