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FDA 510(k)

MINIMAX OXYGENATION SYSTEM

K-Number: K912655 · 1991-09-13

ApplicantMedtronic Vascular
Decision Date1991-09-13
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINIMAX OXYGENATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-09-13 under 510(k) number K912655. 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 MINIMAX OXYGENATION SYSTEM?

MINIMAX OXYGENATION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Medtronic Vascular. The 510(k) number is K912655.

When did MINIMAX OXYGENATION SYSTEM receive FDA 510(k) clearance?

MINIMAX OXYGENATION SYSTEM received FDA 510(k) clearance on 1991-09-13, under 510(k) number K912655.

Who is the listed applicant for MINIMAX OXYGENATION SYSTEM?

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

What is the FDA product code for MINIMAX OXYGENATION SYSTEM?

The FDA product code for MINIMAX OXYGENATION SYSTEM is DTZ.

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Other records listing Medtronic Vascular as applicant

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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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