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FDA 510(k)

MICRO GUIDE CATHETER XP

K-Number: K082143 · 2008-08-25

ApplicantCordis Corp.
Decision Date2008-08-25
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICRO GUIDE CATHETER XP is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 2008-08-25 under 510(k) number K082143. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO GUIDE CATHETER XP?

MICRO GUIDE CATHETER XP is a medical device that received FDA 510(k) clearance on 2008-08-25. The listed applicant is Cordis Corp.. The 510(k) number is K082143.

When did MICRO GUIDE CATHETER XP receive FDA 510(k) clearance?

MICRO GUIDE CATHETER XP received FDA 510(k) clearance on 2008-08-25, under 510(k) number K082143.

Who is the listed applicant for MICRO GUIDE CATHETER XP?

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 MICRO GUIDE CATHETER XP?

The FDA product code for MICRO GUIDE CATHETER XP is PDU.

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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 GUIDEWIREK062798SMART 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 CATHETERK040592CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE

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Related Devices (Code: PDU)

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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