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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 K970690
Device Name LOCKING STYLET 2
Applicant
Cook Pacemaker Corp.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656
Applicant Contact NEAL E FEANOT, PH.D.;E.E.
Correspondent
Cook Pacemaker Corp.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656
Correspondent Contact NEAL E FEANOT, PH.D.;E.E.
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/25/1997
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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