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FDA 510(k)

PLEUR-EVAC CARDIOTOMY RESERVOIR

K-Number: K925046 · 1993-04-20

ApplicantDeknatel, Inc.
Decision Date1993-04-20
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC CARDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K925046. 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 PLEUR-EVAC CARDIOTOMY RESERVOIR?

PLEUR-EVAC CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Deknatel, Inc.. The 510(k) number is K925046.

When did PLEUR-EVAC CARDIOTOMY RESERVOIR receive FDA 510(k) clearance?

PLEUR-EVAC CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 1993-04-20, under 510(k) number K925046.

Who is the listed applicant for PLEUR-EVAC CARDIOTOMY RESERVOIR?

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

What is the FDA product code for PLEUR-EVAC CARDIOTOMY RESERVOIR?

The FDA product code for PLEUR-EVAC CARDIOTOMY RESERVOIR is DTN.

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Other records listing Deknatel, 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.

K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATORK964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGK963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRK925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER

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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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