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FDA 510(k)

BLOOD OXYGENATOR HEAT EXHANGER COATING

K-Number: K833518 · 1983-12-29

ApplicantAmerican Bentley
Decision Date1983-12-29
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD OXYGENATOR HEAT EXHANGER COATING is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K833518. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD OXYGENATOR HEAT EXHANGER COATING?

BLOOD OXYGENATOR HEAT EXHANGER COATING is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is American Bentley. The 510(k) number is K833518.

When did BLOOD OXYGENATOR HEAT EXHANGER COATING receive FDA 510(k) clearance?

BLOOD OXYGENATOR HEAT EXHANGER COATING received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833518.

Who is the listed applicant for BLOOD OXYGENATOR HEAT EXHANGER COATING?

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 BLOOD OXYGENATOR HEAT EXHANGER COATING?

The FDA product code for BLOOD OXYGENATOR HEAT EXHANGER COATING is DTZ.

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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

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Related Devices (Code: DTZ)

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.

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.LK253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura 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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