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FDA 510(k)

SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT

K-Number: K964373 · 1997-06-18

Applicant3M Healthcare
Decision Date1997-06-18
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 1997-06-18 under 510(k) number K964373. 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 SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT?

SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT is a medical device that received FDA 510(k) clearance on 1997-06-18. The listed applicant is 3M Healthcare. The 510(k) number is K964373.

When did SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT receive FDA 510(k) clearance?

SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT received FDA 510(k) clearance on 1997-06-18, under 510(k) number K964373.

Who is the listed applicant for SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT?

The FDA product code for SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT is DWF.

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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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