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FDA 510(k)

TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE

K-Number: K012538 · 2001-08-23

ApplicantMedtronic Vascular
Decision Date2001-08-23
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2001-08-23 under 510(k) number K012538. 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 TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE?

TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE is a medical device that received FDA 510(k) clearance on 2001-08-23. The listed applicant is Medtronic Vascular. The 510(k) number is K012538.

When did TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE receive FDA 510(k) clearance?

TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE received FDA 510(k) clearance on 2001-08-23, under 510(k) number K012538.

Who is the listed applicant for TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE?

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

What is the FDA product code for TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE?

The FDA product code for TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE 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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