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FDA 510(k)

MODIFICATION TO ENVOY AND VISTA BRITE TIP

K-Number: K021593 · 2002-06-13

ApplicantCordis Corp.
Decision Date2002-06-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ENVOY AND VISTA BRITE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 2002-06-13 under 510(k) number K021593. 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 MODIFICATION TO ENVOY AND VISTA BRITE TIP?

MODIFICATION TO ENVOY AND VISTA BRITE TIP is a medical device that received FDA 510(k) clearance on 2002-06-13. The listed applicant is Cordis Corp.. The 510(k) number is K021593.

When did MODIFICATION TO ENVOY AND VISTA BRITE TIP receive FDA 510(k) clearance?

MODIFICATION TO ENVOY AND VISTA BRITE TIP received FDA 510(k) clearance on 2002-06-13, under 510(k) number K021593.

Who is the listed applicant for MODIFICATION TO ENVOY AND VISTA BRITE TIP?

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 MODIFICATION TO ENVOY AND VISTA BRITE TIP?

The FDA product code for MODIFICATION TO ENVOY AND VISTA BRITE TIP 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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