Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K192533 |
Device Name |
Health Line CT CVC |
Applicant |
Health Line International Corporation |
5675 W 300 S |
Salt Lake City,
UT
84117
|
|
Applicant Contact |
Joel K. Faulkner |
Correspondent |
Health Line International Corporation |
5675 W 300 S |
Salt Lake City,
UT
84117
|
|
Correspondent Contact |
Joel K. Faulkner |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/16/2019 |
Decision Date | 12/10/2019 |
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
|
|
|