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FDA 510(k)

TS3 TUBING SET

K-Number: K031151 · 2003-06-26

ApplicantGlobal Blood Resources, LLC
Decision Date2003-06-26
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TS3 TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Global Blood Resources, LLC. It received FDA 510(k) clearance on 2003-06-26 under 510(k) number K031151. 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 TS3 TUBING SET?

TS3 TUBING SET is a medical device that received FDA 510(k) clearance on 2003-06-26. The listed applicant is Global Blood Resources, LLC. The 510(k) number is K031151.

When did TS3 TUBING SET receive FDA 510(k) clearance?

TS3 TUBING SET received FDA 510(k) clearance on 2003-06-26, under 510(k) number K031151.

Who is the listed applicant for TS3 TUBING SET?

The FDA 510(k) record lists Global Blood Resources, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TS3 TUBING SET?

The FDA product code for TS3 TUBING SET 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 Global Blood Resources, LLC 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.

K031150HEMOBAG, MODEL HBBSD2000

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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