Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR

K-Number: K852382 · 1985-09-25

ApplicantAmerican Bentley
Decision Date1985-09-25
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1985-09-25 under 510(k) number K852382. 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/MEDIASTINAL AUTOTRANSFUSION RESERVOIR?

CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR is a medical device that received FDA 510(k) clearance on 1985-09-25. The listed applicant is American Bentley. The 510(k) number is K852382.

When did CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR receive FDA 510(k) clearance?

CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR received FDA 510(k) clearance on 1985-09-25, under 510(k) number K852382.

Who is the listed applicant for CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR?

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

What is the FDA product code for CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR?

The FDA product code for CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR is DTN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Bentley 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.

K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERK870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100K872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUSK870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY

View all 59 devices →

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.

↑