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FDA 510(k)

SHILEY HARDSHELL VENOUS RESERVOIR W/INT

K-Number: K843232 · 1985-01-14

ApplicantShiley, Inc.
Decision Date1985-01-14
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY HARDSHELL VENOUS RESERVOIR W/INT is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1985-01-14 under 510(k) number K843232. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY HARDSHELL VENOUS RESERVOIR W/INT?

SHILEY HARDSHELL VENOUS RESERVOIR W/INT is a medical device that received FDA 510(k) clearance on 1985-01-14. The listed applicant is Shiley, Inc.. The 510(k) number is K843232.

When did SHILEY HARDSHELL VENOUS RESERVOIR W/INT receive FDA 510(k) clearance?

SHILEY HARDSHELL VENOUS RESERVOIR W/INT received FDA 510(k) clearance on 1985-01-14, under 510(k) number K843232.

Who is the listed applicant for SHILEY HARDSHELL VENOUS RESERVOIR W/INT?

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 HARDSHELL VENOUS RESERVOIR W/INT?

The FDA product code for SHILEY HARDSHELL VENOUS RESERVOIR W/INT is DTN.

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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: DTN)

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.

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac SurgeryK223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia 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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