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FDA 510(k)

CARDIOTOMY RESERVOIR W/FILTER

K-Number: K843595 · 1985-02-14

ApplicantOmnis Surgical, Inc.
Decision Date1985-02-14
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR W/FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Omnis Surgical, Inc.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K843595. 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 CARDIOTOMY RESERVOIR W/FILTER?

CARDIOTOMY RESERVOIR W/FILTER is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Omnis Surgical, Inc.. The 510(k) number is K843595.

When did CARDIOTOMY RESERVOIR W/FILTER receive FDA 510(k) clearance?

CARDIOTOMY RESERVOIR W/FILTER received FDA 510(k) clearance on 1985-02-14, under 510(k) number K843595.

Who is the listed applicant for CARDIOTOMY RESERVOIR W/FILTER?

The FDA 510(k) record lists Omnis Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOTOMY RESERVOIR W/FILTER?

The FDA product code for CARDIOTOMY RESERVOIR W/FILTER is DTN.

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Other records listing Omnis Surgical, 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.

K854518EPIDURAL ANESTHESIA TRAYK850979HEMOCONCENTRATOR KITK844993COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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