Cleared Traditional

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

K162457 · Rocket Medical Plc · Gastroenterology & Urology
Nov 2016
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K162457 is an FDA 510(k) clearance for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit, a Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (Class II — Special Controls, product code PNG), submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on November 14, 2016, 73 days after receiving the submission on September 2, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K162457 FDA.gov
FDA Decision Cleared SEKD
Date Received September 02, 2016
Decision Date November 14, 2016
Days to Decision 73 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630
Definition For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity.

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