FDA 510(k)

TORQUE CONTROL BALLOON CATHETER

K-Number: K802338 · 1980-10-10

Decision Date1980-10-10

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TORQUE CONTROL 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 1980-10-10 under 510(k) number K802338. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORQUE CONTROL BALLOON CATHETER?

TORQUE CONTROL BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Cordis Corp.. The 510(k) number is K802338.

When did TORQUE CONTROL BALLOON CATHETER receive FDA 510(k) clearance?

TORQUE CONTROL BALLOON CATHETER received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802338.

Who is the listed applicant for TORQUE CONTROL 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 TORQUE CONTROL BALLOON CATHETER?

The FDA product code for TORQUE CONTROL BALLOON CATHETER is DYG.

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Other records listing Cordis Corp. as applicant

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER K101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE K082143MICRO GUIDE CATHETER XP K062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB K060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX K050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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Related Devices (Code: DYG)

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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.