Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K160925 |
FOIA Releasable 510(k) |
K160925
|
Device Name |
VPS Rhythm Device with TipTracker Technology |
Applicant |
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
KARL J. NITTINGER |
Correspondent |
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
Christine Ford |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 04/04/2016 |
Decision Date | 12/22/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|