Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K150109 |
Device Name |
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology |
Applicant |
Arrow International ( a subsidiary of Teleflex, Inc.) |
2400 Bernville Rd. |
Reading,
PA
19605
|
|
Applicant Contact |
Karl J Nittinger |
Correspondent |
Arrow International (a subsidiary of Teleflex, Inc.) |
2400 Bernville Rd. |
Reading,
PA
19605
|
|
Correspondent Contact |
Karl J Nittinger |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/20/2015 |
Decision Date | 06/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|