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FDA 510(k)

SAFE MICRO

K-Number: K953976 · 1997-02-04

ApplicantPolystan A/S
Decision Date1997-02-04
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFE MICRO 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 1997-02-04 under 510(k) number K953976. 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 MICRO?

SAFE MICRO is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Polystan A/S. The 510(k) number is K953976.

When did SAFE MICRO receive FDA 510(k) clearance?

SAFE MICRO received FDA 510(k) clearance on 1997-02-04, under 510(k) number K953976.

Who is the listed applicant for SAFE MICRO?

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 MICRO?

The FDA product code for SAFE MICRO 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.

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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 CANNULAK013038SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010K022281SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045K980974SAFE MINIK912082SAFE 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.

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