Device Classification Name |
reprocessed catheter introducer
|
510(k) Number |
K152090 |
Device Name |
Reprocessed Steerable Introducer |
Applicant |
STERILMED, INC. |
5010 Cheshire Parkway N, Suite 2 |
Plymouth,
MN
55446
|
|
Applicant Contact |
Patricia Kaufman |
Correspondent |
Libra Medical Inc. |
8401 63rd Avenue North, Suite 63 |
Brooklyn Park,
MN
55428
|
|
Correspondent Contact |
Ming Cheng Chew |
Regulation Number | 870.1340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/27/2015 |
Decision Date | 03/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|