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FDA 510(k)

BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES

K-Number: K892641 · 1989-11-01

ApplicantBard Cardiosurgery Div
Decision Date1989-11-01
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES is the device name listed in this FDA 510(k) record. The listed applicant is Bard Cardiosurgery Div. It received FDA 510(k) clearance on 1989-11-01 under 510(k) number K892641. 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 BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES?

BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES is a medical device that received FDA 510(k) clearance on 1989-11-01. The listed applicant is Bard Cardiosurgery Div. The 510(k) number is K892641.

When did BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES receive FDA 510(k) clearance?

BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES received FDA 510(k) clearance on 1989-11-01, under 510(k) number K892641.

Who is the listed applicant for BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES?

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

What is the FDA product code for BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES?

The FDA product code for BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES is DTZ.

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Other records listing Bard Cardiosurgery Div 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.

K913915BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERVK892664CARDIOPULMONARY SUPPORT (CPS) SYSTEM

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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