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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K231279
Device Name Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
Applicant
Ablative Solutions, Inc.
301 Edgewater Place
Suite 100
Wakefield,  MA  01880
Applicant Contact Kristine Canavan
Correspondent
Ablative Solutions, Inc.
301 Edgewater Place
Suite 100
Wakefield,  MA  01880
Correspondent Contact Kristine Canavan
Regulation Number870.1210
Classification Product Code
KRA  
Date Received05/03/2023
Decision Date 07/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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