Device Classification Name |
Aspiration Thrombectomy Catheter
|
510(k) Number |
K083784 |
Device Name |
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
CHARMAINE SUTTON |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
CHARMAINE SUTTON |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 12/19/2008 |
Decision Date | 03/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|