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)

SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010

K-Number: K013038 · 2002-08-14

ApplicantPolystan A/S
Decision Date2002-08-14
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 is the device name listed in this FDA 510(k) record. The listed applicant is Polystan A/S. It received FDA 510(k) clearance on 2002-08-14 under 510(k) number K013038. 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 SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010?

SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 is a medical device that received FDA 510(k) clearance on 2002-08-14. The listed applicant is Polystan A/S. The 510(k) number is K013038.

When did SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 receive FDA 510(k) clearance?

SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 received FDA 510(k) clearance on 2002-08-14, under 510(k) number K013038.

Who is the listed applicant for SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010?

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

What is the FDA product code for SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010?

The FDA product code for SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 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 Polystan A/S 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.

K023251PEDIATRIC ARTERIAL CANNULAK022281SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045K980974SAFE MINIK953976SAFE MICROK912082SAFE II

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.

↑