Cleared Traditional

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

K163321 · Rocket Medical Plc · Anesthesiology
Aug 2017
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K163321 is an FDA 510(k) clearance for the Rocket Indwelling Pleural Catheter (IPC) Insertion Kit, a Apparatus, Suction, Patient Care (Class II — Special Controls, product code DWM), submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on August 17, 2017, 265 days after receiving the submission on November 25, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.

Submission Details

510(k) Number K163321 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2016
Decision Date August 17, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DWM — Apparatus, Suction, Patient Care
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5050

Similar Devices — DWM Apparatus, Suction, Patient Care

All 18
Aspira Pleural Drainage System
K212696 · Merit Medical Systems, Inc. · Mar 2023
Rocket Platinum Cured Cathter
K210509 · Rocket Medical Plc · Sep 2021
Passio Pump Drainage System
K201404 · Bearpac Medical · Nov 2020
Passio Pump Drainage System
K190292 · Bearpac Medical · Jul 2019
Pleurx Pleural Catheter System
K160450 · Care Fusion · Oct 2016
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
K141965 · Care Fusion · Jul 2015