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FDA 510(k)

OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER

K-Number: K981407 · 1998-05-20

ApplicantCordis Corp.
Decision Date1998-05-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K981407. 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 OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER?

OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Cordis Corp.. The 510(k) number is K981407.

When did OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER receive FDA 510(k) clearance?

OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981407.

Who is the listed applicant for OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER?

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

What is the FDA product code for OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER?

The FDA product code for OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER is LIT.

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Other records listing Cordis Corp. 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.

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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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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