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FDA 510(k)

CORDIS M3 PTA DILATATION CATHETER

K-Number: K003920 · 2001-06-15

ApplicantCordis Corp.
Decision Date2001-06-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS M3 PTA DILATATION 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 2001-06-15 under 510(k) number K003920. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIS M3 PTA DILATATION CATHETER?

CORDIS M3 PTA DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2001-06-15. The listed applicant is Cordis Corp.. The 510(k) number is K003920.

When did CORDIS M3 PTA DILATATION CATHETER receive FDA 510(k) clearance?

CORDIS M3 PTA DILATATION CATHETER received FDA 510(k) clearance on 2001-06-15, under 510(k) number K003920.

Who is the listed applicant for CORDIS M3 PTA DILATATION 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 CORDIS M3 PTA DILATATION CATHETER?

The FDA product code for CORDIS M3 PTA DILATATION CATHETER is DQY.

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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: DQY)

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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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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