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FDA 510(k)

FOX PLUS PTA CATHETER

K-Number: K040954 · 2004-05-11

ApplicantAbbott Laboratories, Inc.
Decision Date2004-05-11
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOX PLUS PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories, Inc.. It received FDA 510(k) clearance on 2004-05-11 under 510(k) number K040954. 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 FOX PLUS PTA CATHETER?

FOX PLUS PTA CATHETER is a medical device that received FDA 510(k) clearance on 2004-05-11. The listed applicant is Abbott Laboratories, Inc.. The 510(k) number is K040954.

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

FOX PLUS PTA CATHETER received FDA 510(k) clearance on 2004-05-11, under 510(k) number K040954.

Who is the listed applicant for FOX PLUS PTA CATHETER?

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

What is the FDA product code for FOX PLUS PTA CATHETER?

The FDA product code for FOX PLUS PTA CATHETER is LIT.

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Other records listing Abbott Laboratories, Inc. 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.

K090358ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35K061193CREATININEK051213PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPSK040761AXSYM CYCLOSPORINEK023062GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

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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