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FDA 510(k)

SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045

K-Number: K022281 · 2002-08-06

ApplicantPolystan A/S
Decision Date2002-08-06
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 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 2002-08-06 under 510(k) number K022281. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045?

SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 is a medical device that received FDA 510(k) clearance on 2002-08-06. The listed applicant is Polystan A/S. The 510(k) number is K022281.

When did SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 receive FDA 510(k) clearance?

SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 received FDA 510(k) clearance on 2002-08-06, under 510(k) number K022281.

Who is the listed applicant for SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045?

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 VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045?

The FDA product code for SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 is DTN.

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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 016010K980974SAFE MINIK953976SAFE MICROK912082SAFE II

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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