Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
510(k) Number |
K113354 |
Device Name |
VETA PERITONEAL DIALYSIS CATHETER |
Applicant |
PFM MEDICAL, INC |
1815 ASTON AVE |
SUITE 106 |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
SALVADORE PALOMARES |
Correspondent |
PFM MEDICAL, INC |
1815 ASTON AVE |
SUITE 106 |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
SALVADORE PALOMARES |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 11/14/2011 |
Decision Date | 03/13/2012 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|