Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K193278 |
Device Name |
MedSource CathMED IV Catheter |
Applicant |
MedSource Labs |
4201 Norex Drive |
Chaska,
MN
55318
|
|
Applicant Contact |
Emilie Andrews |
Correspondent |
MedSource Labs |
4201 Norex Drive |
Chaska,
MN
55318
|
|
Correspondent Contact |
Emilie Andrews |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 11/27/2019 |
Decision Date | 08/07/2020 |
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
|
|
|