Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K212151 |
Device Name |
FLUME catheter |
Applicant |
The Flume Catheter Company, Ltd. |
The Granary, Millhouse |
Frensham,
GB
GU10 3EE
|
|
Applicant Contact |
Roger Holmes |
Correspondent |
Paladin Medical, Inc. |
PO Box 560 |
Stillwater,
MN
55082
|
|
Correspondent Contact |
Elaine Duncan |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 07/09/2021 |
Decision Date | 11/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|