Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K190716 |
Device Name |
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead |
Applicant |
Medtronic |
1851 East Deere Ave. |
Santa Ana,
CA
92705
|
|
Applicant Contact |
Joven Almazan |
Correspondent |
Medtronic |
1851 East Deere Ave. |
Santa Ana,
CA
92705
|
|
Correspondent Contact |
Joven Almazan |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 03/19/2019 |
Decision Date | 08/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|