Device Classification Name |
introducer, catheter
|
510(k) Number |
K920907 |
Device Name |
OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO |
Applicant |
Teleflex Medical, Inc. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
JO RUDZIDENSKY |
Correspondent |
Teleflex Medical, Inc. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
JO RUDZIDENSKY |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 02/27/1992 |
Decision Date | 10/06/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|