Device Classification Name |
device, intravascular catheter securement
|
510(k) Number |
K180994 |
Device Name |
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F |
Applicant |
Interrad Medical Inc |
181 Cheshire Lane, Suite 100 |
Plymouth,
MN
55441
|
|
Applicant Contact |
Denise Lenz |
Correspondent |
Libra Medical, Inc |
8401 73rd Ave North, Suite 63 |
Minneapolis,
MN
55428
|
|
Correspondent Contact |
Denise Lenz |
Regulation Number | 880.5210
|
Classification Product Code |
|
Date Received | 04/16/2018 |
Decision Date | 07/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|