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FDA 510(k)

THB 6000 HARDSHELL BUBBLE OXYGENATOR

K-Number: K803231 · 1981-01-16

ApplicantTravenol Laboratories, S.A.
Decision Date1981-01-16
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THB 6000 HARDSHELL BUBBLE OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803231. 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 THB 6000 HARDSHELL BUBBLE OXYGENATOR?

THB 6000 HARDSHELL BUBBLE OXYGENATOR is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K803231.

When did THB 6000 HARDSHELL BUBBLE OXYGENATOR receive FDA 510(k) clearance?

THB 6000 HARDSHELL BUBBLE OXYGENATOR received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803231.

Who is the listed applicant for THB 6000 HARDSHELL BUBBLE OXYGENATOR?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THB 6000 HARDSHELL BUBBLE OXYGENATOR?

The FDA product code for THB 6000 HARDSHELL BUBBLE OXYGENATOR is DTZ.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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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