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FDA 510(k)

PARTNER SEVEN DISP. BUBBLE OXYGENATOR

K-Number: K800555 · 1980-04-04

ApplicantCardiovascular Research, Inc.
Decision Date1980-04-04
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PARTNER SEVEN DISP. BUBBLE OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Research, Inc.. It received FDA 510(k) clearance on 1980-04-04 under 510(k) number K800555. 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 PARTNER SEVEN DISP. BUBBLE OXYGENATOR?

PARTNER SEVEN DISP. BUBBLE OXYGENATOR is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Cardiovascular Research, Inc.. The 510(k) number is K800555.

When did PARTNER SEVEN DISP. BUBBLE OXYGENATOR receive FDA 510(k) clearance?

PARTNER SEVEN DISP. BUBBLE OXYGENATOR received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800555.

Who is the listed applicant for PARTNER SEVEN DISP. BUBBLE OXYGENATOR?

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

What is the FDA product code for PARTNER SEVEN DISP. BUBBLE OXYGENATOR?

The FDA product code for PARTNER SEVEN DISP. BUBBLE OXYGENATOR is DTZ.

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.

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Other records listing Cardiovascular Research, 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.

K843118CANNULA INTRODUCER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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