Device Classification Name |
introducer, catheter
|
510(k) Number |
K112887 |
Device Name |
UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR |
Applicant |
UPSTREAM PERIPHERAL TECHNOLOGIES |
1835 MARKET STREET |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JANICE M HOGAN |
Correspondent |
UPSTREAM PERIPHERAL TECHNOLOGIES |
1835 MARKET STREET |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE M HOGAN |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 03/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|