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FDA 510(k)

PEDIATRIC ARTERIAL CANNULA

K-Number: K023251 · 2002-12-04

ApplicantPolystan A/S
Decision Date2002-12-04
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC ARTERIAL CANNULA 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 2002-12-04 under 510(k) number K023251. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC ARTERIAL CANNULA?

PEDIATRIC ARTERIAL CANNULA is a medical device that received FDA 510(k) clearance on 2002-12-04. The listed applicant is Polystan A/S. The 510(k) number is K023251.

When did PEDIATRIC ARTERIAL CANNULA receive FDA 510(k) clearance?

PEDIATRIC ARTERIAL CANNULA received FDA 510(k) clearance on 2002-12-04, under 510(k) number K023251.

Who is the listed applicant for PEDIATRIC ARTERIAL CANNULA?

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 PEDIATRIC ARTERIAL CANNULA?

The FDA product code for PEDIATRIC ARTERIAL CANNULA is DWF.

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.

K013038SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010K022281SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045K980974SAFE MINIK953976SAFE MICROK912082SAFE II

Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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