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FDA 510(k)

INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C

K-Number: K042984 · 2005-02-18

ApplicantIntervascular
Decision Date2005-02-18
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular. It received FDA 510(k) clearance on 2005-02-18 under 510(k) number K042984. 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 INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C?

INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Intervascular. The 510(k) number is K042984.

When did INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C receive FDA 510(k) clearance?

INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C received FDA 510(k) clearance on 2005-02-18, under 510(k) number K042984.

Who is the listed applicant for INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C?

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

What is the FDA product code for INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C?

The FDA product code for INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C is DWF.

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Other records listing Intervascular 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.

K022242INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZERK013651INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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