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FDA 510(k)

INTERPULSE MEMBRANE OXYGENATOR

K-Number: K821216 · 1982-06-02

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1982-06-02
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERPULSE MEMBRANE OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1982-06-02 under 510(k) number K821216. 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 INTERPULSE MEMBRANE OXYGENATOR?

INTERPULSE MEMBRANE OXYGENATOR is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K821216.

When did INTERPULSE MEMBRANE OXYGENATOR receive FDA 510(k) clearance?

INTERPULSE MEMBRANE OXYGENATOR received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821216.

Who is the listed applicant for INTERPULSE MEMBRANE OXYGENATOR?

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

What is the FDA product code for INTERPULSE MEMBRANE OXYGENATOR?

The FDA product code for INTERPULSE MEMBRANE OXYGENATOR is DTZ.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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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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