Device Classification Name |
midline catheter
|
510(k) Number |
K181208 |
Device Name |
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter |
Applicant |
Vygon USA |
2750 Morris Rd |
Suite A200 |
Lansdale,
PA
19460
|
|
Applicant Contact |
Jillian Mikovich |
Correspondent |
Vygon USA |
2750 Morris Rd |
Suite A200 |
Lansdale,
PA
19460
|
|
Correspondent Contact |
Jillian Mikovich |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/07/2018 |
Decision Date | 11/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|