Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K083343 |
Device Name |
HEADWAY 17 MICROCATHETER |
Applicant |
MICROVENTION, INC. |
75 COLUMBIA |
SUITE A |
ALISO VIEJO,
CA
92656 -1408
|
|
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/13/2008 |
Decision Date | 12/04/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|