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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K910969
Device Name TORQUE DEVICE FOR A GUIDE WIRE
Applicant
Terumo Corp.
2100 Cottontail Ln.
Somerset,  NJ  08873
Applicant Contact MIKE ICHIYANAGI
Correspondent
Terumo Corp.
2100 Cottontail Ln.
Somerset,  NJ  08873
Correspondent Contact MIKE ICHIYANAGI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/06/1991
Decision Date 05/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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