Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K200263 |
Device Name |
Health Line CT Midline Catheter |
Applicant |
Health Line International Corporation |
5675 W 300 S |
Salt Lake City,
UT
84104
|
|
Applicant Contact |
Aaron G Faulkner |
Correspondent |
Health Line International Corporation |
5675 W 300 S |
Salt Lake City,
UT
84104
|
|
Correspondent Contact |
Aaron G Faulkner |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 02/03/2020 |
Decision Date | 03/12/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|