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FDA 510(k)

EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER

K-Number: K112513 · 2011-12-09

ApplicantNatec Medical , Ltd.
Decision Date2011-12-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Natec Medical , Ltd.. It received FDA 510(k) clearance on 2011-12-09 under 510(k) number K112513. 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 EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER?

EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-12-09. The listed applicant is Natec Medical , Ltd.. The 510(k) number is K112513.

When did EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER receive FDA 510(k) clearance?

EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance on 2011-12-09, under 510(k) number K112513.

Who is the listed applicant for EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER?

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

What is the FDA product code for EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER?

The FDA product code for EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER is LIT.

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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

View on FDA Database →

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

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