Device Classification Name |
Clamp, Vascular
|
510(k) Number |
K110193 |
Device Name |
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F |
Applicant |
ST. JUDE MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
SE-751 35
|
|
Applicant Contact |
KATRIN SVENSSON |
Correspondent |
ST. JUDE MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
SE-751 35
|
|
Correspondent Contact |
KATRIN SVENSSON |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 01/24/2011 |
Decision Date | 02/24/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|