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FDA 510(k)

SHILEY BCD PLUS HEAT EXCHANGER

K-Number: K880663 · 1988-05-11

ApplicantShiley, Inc.
Decision Date1988-05-11
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY BCD PLUS HEAT EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K880663. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY BCD PLUS HEAT EXCHANGER?

SHILEY BCD PLUS HEAT EXCHANGER is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Shiley, Inc.. The 510(k) number is K880663.

When did SHILEY BCD PLUS HEAT EXCHANGER receive FDA 510(k) clearance?

SHILEY BCD PLUS HEAT EXCHANGER received FDA 510(k) clearance on 1988-05-11, under 510(k) number K880663.

Who is the listed applicant for SHILEY BCD PLUS HEAT EXCHANGER?

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 BCD PLUS HEAT EXCHANGER?

The FDA product code for SHILEY BCD PLUS HEAT EXCHANGER is DTR.

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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: DTR)

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.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

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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