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FDA 510(k)

VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER

K-Number: K072798 · 2008-01-31

ApplicantAbbott Vascular-Vascular Solutions
Decision Date2008-01-31
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular-Vascular Solutions. It received FDA 510(k) clearance on 2008-01-31 under 510(k) number K072798. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER?

VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2008-01-31. The listed applicant is Abbott Vascular-Vascular Solutions. The 510(k) number is K072798.

When did VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER receive FDA 510(k) clearance?

VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER received FDA 510(k) clearance on 2008-01-31, under 510(k) number K072798.

Who is the listed applicant for VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER?

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

What is the FDA product code for VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER?

The FDA product code for VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER is LIT.

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Other records listing Abbott Vascular-Vascular Solutions 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.

K090665EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19K090509FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETERK081523EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEMK072708ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEMK080264MODIFICATION TO: FOX PLUS PTA CATHETER

Related Devices (Code: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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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