Device Classification Name |
Electrode, Pacemaker, Temporary
|
510(k) Number |
K960479 |
Device Name |
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER |
Applicant |
ARROW INTL., INC. |
3000 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
3000 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 02/02/1996 |
Decision Date | 10/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|