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FDA 510(k)

STOCKERT-SHILEY CAPS HLM INTERFACE

K-Number: K863541 · 1986-11-18

ApplicantShiley, Inc.
Decision Date1986-11-18
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT-SHILEY CAPS HLM INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1986-11-18 under 510(k) number K863541. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT-SHILEY CAPS HLM INTERFACE?

STOCKERT-SHILEY CAPS HLM INTERFACE is a medical device that received FDA 510(k) clearance on 1986-11-18. The listed applicant is Shiley, Inc.. The 510(k) number is K863541.

When did STOCKERT-SHILEY CAPS HLM INTERFACE receive FDA 510(k) clearance?

STOCKERT-SHILEY CAPS HLM INTERFACE received FDA 510(k) clearance on 1986-11-18, under 510(k) number K863541.

Who is the listed applicant for STOCKERT-SHILEY CAPS HLM INTERFACE?

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 STOCKERT-SHILEY CAPS HLM INTERFACE?

The FDA product code for STOCKERT-SHILEY CAPS HLM INTERFACE is DTQ.

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Other records listing Shiley, Inc. as applicant

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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: DTQ)

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.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

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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