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510(k) K152105

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set by Rocket Medical Plc — Product Code PNG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 29, 2016
Date Received
July 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

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  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)

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