Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K191687 |
Device Name |
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire |
Applicant |
phenox Limited |
Kamrick Court, Ballybrit Business Park |
Galway,
IE
H91XY38
|
|
Applicant Contact |
Gary Brogan |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 870.1330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/24/2019 |
Decision Date | 10/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|