Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K042264 |
Device Name |
GUIDEWIRES |
Applicant |
ROCKET MEDICAL PLC |
WEAR INDUSTRIAL ESTATE |
WASHINGTON, TYNE & WEAR,
GB
NE37 1NE
|
|
Applicant Contact |
T. CHARLTON |
Correspondent |
ROCKET MEDICAL PLC |
WEAR INDUSTRIAL ESTATE |
WASHINGTON, TYNE & WEAR,
GB
NE37 1NE
|
|
Correspondent Contact |
T. CHARLTON |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 08/23/2004 |
Decision Date | 11/24/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|