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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K190106
Device Name Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
Applicant
Centerline Biomedical, Inc.
10000 Cedar Ave.
Cleveland,  OH  44106
Applicant Contact Vikash Goel
Correspondent
Jalex Medical
30311 Clemens Rd. Suite 5d
Westlake,  OH  44145
Correspondent Contact Lauren Smith
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/22/2019
Decision Date 06/24/2019
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
Recalls CDRH Recalls
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