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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 K050756
Device Name SKIPPER AND SKIPPER RACE GUIDEWIRE
Applicant
Invatec Innovative Technologies, S.R.L.
4600 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact MELISSA SOMMERFELD
Correspondent
Invatec Innovative Technologies, S.R.L.
4600 Nathan Ln. N
Plymouth,  MN  55442
Correspondent Contact MELISSA SOMMERFELD
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/23/2005
Decision Date 05/05/2005
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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