Device Classification Name |
mechanical thrombolysis catheter
|
510(k) Number |
K951509 |
Device Name |
PULSE*SPRAY INFUSION SYSTEM |
Applicant |
ANGIODYNAMICS, DIV. E-Z-EM, INC. |
266 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Applicant Contact |
JODI L FRASIER |
Correspondent |
ANGIODYNAMICS, DIV. E-Z-EM, INC. |
266 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Correspondent Contact |
JODI L FRASIER |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 06/16/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|