Device Classification Name |
Apparatus, Suction, Patient Care
|
510(k) Number |
K163321 |
Device Name |
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit |
Applicant |
ROCKET MEDICAL PLC |
2-4 SEDLING RD, WEAR INDUSTRIAL ESTATE |
WASHINGTON,
GB
NE38 9BZ
|
|
Applicant Contact |
Tracy Charlton |
Correspondent |
ROCKET MEDICAL PLC |
2-4 SEDLING RD, WEAR INDUSTRIAL ESTATE |
WASHINGTON,
GB
NE38 9BZ
|
|
Correspondent Contact |
Tracy Charlton |
Regulation Number | 870.5050
|
Classification Product Code |
|
Date Received | 11/25/2016 |
Decision Date | 08/17/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|