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FDA 510(k)

WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR

K-Number: K894970 · 1989-11-01

ApplicantMinntech Corp.
Decision Date1989-11-01
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1989-11-01 under 510(k) number K894970. 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 WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR?

WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR is a medical device that received FDA 510(k) clearance on 1989-11-01. The listed applicant is Minntech Corp.. The 510(k) number is K894970.

When did WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR receive FDA 510(k) clearance?

WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR received FDA 510(k) clearance on 1989-11-01, under 510(k) number K894970.

Who is the listed applicant for WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR?

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

What is the FDA product code for WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR?

The FDA product code for WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR is DTZ.

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Other records listing Minntech Corp. 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.

K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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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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