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)

HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000

K-Number: K833078 · 1984-01-27

ApplicantCordis Corp.
Decision Date1984-01-27
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1984-01-27 under 510(k) number K833078. 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 HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000?

HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 is a medical device that received FDA 510(k) clearance on 1984-01-27. The listed applicant is Cordis Corp.. The 510(k) number is K833078.

When did HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 receive FDA 510(k) clearance?

HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 received FDA 510(k) clearance on 1984-01-27, under 510(k) number K833078.

Who is the listed applicant for HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000?

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

What is the FDA product code for HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000?

The FDA product code for HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 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 Cordis Corp. 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.

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

View all 314 devices →

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.

↑