Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

K-Number: K050447 · 2005-03-08

ApplicantDideco S.R.L.
Decision Date2005-03-08
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dideco S.R.L.. It received FDA 510(k) clearance on 2005-03-08 under 510(k) number K050447. 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 PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR?

PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR is a medical device that received FDA 510(k) clearance on 2005-03-08. The listed applicant is Dideco S.R.L.. The 510(k) number is K050447.

When did PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR receive FDA 510(k) clearance?

PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR received FDA 510(k) clearance on 2005-03-08, under 510(k) number K050447.

Who is the listed applicant for PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR?

The FDA 510(k) record lists Dideco S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR?

The FDA product code for PERFORMA ADULT HOLLOW FIBER MEMBRANE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dideco S.R.L. 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.

K052717D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTERK051232D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTERK050890ECC.O SYSTEMK043323D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRK953835LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

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.

↑