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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K260304
Device Name WAVE PTA Balloon Catheter
Applicant
WAVE Medical AG
Industrieplatz 1e
Bldg. 53
Neuhausen Am Rheinfall,  CH 8212
Applicant Contact Kym Rupp
Correspondent
WAVE Medical AG
Industrieplatz 1e
Bldg. 53
Neuhausen Am Rheinfall,  CH 8212
Correspondent Contact Kym Rupp
Regulation Number870.1250
Classification Product Code
LIT  
Date Received01/30/2026
Decision Date 05/20/2026
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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