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 Number | 870.1425
|
Classification Product Code |
|
Date Received | 01/22/2019 |
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
|
|
|