Device Classification Name |
introducer, catheter
|
510(k) Number |
K851141 |
Device Name |
TELEFLEX MEDICAL INTRODUCER CATHETER |
Applicant |
Teleflex Medical, Inc. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
HERBERT M CARTER |
Correspondent |
Teleflex Medical, Inc. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
HERBERT M CARTER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/21/1985 |
Decision Date | 05/16/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|