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FDA 510(k)

TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA

K-Number: K062597 · 2006-11-03

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2006-11-03
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2006-11-03 under 510(k) number K062597. 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 TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA?

TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA is a medical device that received FDA 510(k) clearance on 2006-11-03. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K062597.

When did TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA receive FDA 510(k) clearance?

TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA received FDA 510(k) clearance on 2006-11-03, under 510(k) number K062597.

Who is the listed applicant for TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA?

The FDA product code for TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA 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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