Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K152876 |
Device Name |
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM |
Applicant |
TNI Manufacturing, Inc. |
4635 NW 103rd Avenue |
Sunrise,
FL
33351
|
|
Applicant Contact |
DANIEL SABLYAK |
Correspondent |
INNEUROCO |
4635 NW 103RD AVENU |
SUNRISE,
FL
33351
|
|
Correspondent Contact |
MARIANNE GRUNWALDT |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/30/2015 |
Decision Date | 01/08/2016 |
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
|
|
|