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FDA 510(k)

MODIFICATION TO: FOX PLUS PTA CATHETER

K-Number: K080264 · 2008-03-26

ApplicantAbbott Vascular-Vascular Solutions
Decision Date2008-03-26
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: FOX PLUS PTA 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 2008-03-26 under 510(k) number K080264. 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 MODIFICATION TO: FOX PLUS PTA CATHETER?

MODIFICATION TO: FOX PLUS PTA CATHETER is a medical device that received FDA 510(k) clearance on 2008-03-26. The listed applicant is Abbott Vascular-Vascular Solutions. The 510(k) number is K080264.

When did MODIFICATION TO: FOX PLUS PTA CATHETER receive FDA 510(k) clearance?

MODIFICATION TO: FOX PLUS PTA CATHETER received FDA 510(k) clearance on 2008-03-26, under 510(k) number K080264.

Who is the listed applicant for MODIFICATION TO: FOX PLUS PTA 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 MODIFICATION TO: FOX PLUS PTA CATHETER?

The FDA product code for MODIFICATION TO: FOX PLUS PTA 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 SYSTEMK072798VIATRAC 14 PLUS PERIPHERAL DILATION 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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