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FDA 510(k)

CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER

K-Number: K063563 · 2007-03-07

ApplicantCordis Europa, N.V.
Decision Date2007-03-07
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Europa, N.V.. It received FDA 510(k) clearance on 2007-03-07 under 510(k) number K063563. 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 CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER?

CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2007-03-07. The listed applicant is Cordis Europa, N.V.. The 510(k) number is K063563.

When did CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2007-03-07, under 510(k) number K063563.

Who is the listed applicant for CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER?

The FDA 510(k) record lists Cordis Europa, N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER?

The FDA product code for CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER is LIT.

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Other records listing Cordis Europa, N.V. 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.

K071189CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETERK060302INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDEDK043605INSCOPE 3-STAGE BALLOON DILATORK040413CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMK032737CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTAK012056CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM

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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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