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FDA 510(k)

MODIFICATION TO FOX PTA CATHETER

K-Number: K020854 · 2002-04-11

ApplicantJomed AG
Decision Date2002-04-11
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FOX PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Jomed AG. It received FDA 510(k) clearance on 2002-04-11 under 510(k) number K020854. 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 PTA CATHETER?

MODIFICATION TO FOX PTA CATHETER is a medical device that received FDA 510(k) clearance on 2002-04-11. The listed applicant is Jomed AG. The 510(k) number is K020854.

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

MODIFICATION TO FOX PTA CATHETER received FDA 510(k) clearance on 2002-04-11, under 510(k) number K020854.

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

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

What is the FDA product code for MODIFICATION TO FOX PTA CATHETER?

The FDA product code for MODIFICATION TO FOX PTA CATHETER is LIT.

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 Jomed AG 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.

K030053JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810K010838FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008

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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