Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K883880 |
Device Name |
KATZEN THROMBOLYSIS GUIDEWIRE |
Applicant |
MEDI-TECH, INC. |
480 PLESANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Applicant Contact |
ALBERT SEPRINSKI |
Correspondent |
MEDI-TECH, INC. |
480 PLESANT ST. |
P.O. BOX 7407 |
WATERTOWN,
MA
02272
|
|
Correspondent Contact |
ALBERT SEPRINSKI |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 09/13/1988 |
Decision Date | 04/06/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|