Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K880298 |
Device Name |
PERIPHERAL DILATATION CATHETER |
Applicant |
MEDI-TECH, INC. |
480 PLESANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Applicant Contact |
ALBERT P SEPRINSKI |
Correspondent |
MEDI-TECH, INC. |
480 PLESANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Correspondent Contact |
ALBERT P SEPRINSKI |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/25/1988 |
Decision Date | 04/22/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|