Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K221390 |
Device Name |
BNLE Access Guidewire |
Applicant |
Biomerics NLE |
10351 Xylon Ave N., Suite 100 |
Brooklyn Park,
MN
55445
|
|
Applicant Contact |
Jason Albers |
Correspondent |
MedVenture Health |
299S Main St., Suite 2300 |
Salt Lake City,
UT
84111
|
|
Correspondent Contact |
Jonathan Holmes |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 05/13/2022 |
Decision Date | 04/28/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|