Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K190855 |
Device Name |
BD Acute Central Line |
Applicant |
Bard Access Systems, Inc. (Bard has joined BD) |
605 North 5600 West |
Salt Lake City,
UT
84116
|
|
Applicant Contact |
Sean J. Loring |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
Dave Yungvirt |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/02/2019 |
Decision Date | 11/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|