Device Classification Name |
Catheter, Flow Directed
|
510(k) Number |
K822806 |
Device Name |
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC |
Applicant |
NOVA MEDICAL SPECIALTIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
NOVA MEDICAL SPECIALTIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.1240
|
Classification Product Code |
|
Date Received | 09/17/1982 |
Decision Date | 11/01/1982 |
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
|
|
|