# K210509: Rocket Platinum Cured Cathter

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Sep 9, 2021 after 199 days
- Product code: DWM (Apparatus, Suction, Patient Care)
- Device class: 2
- Regulation: 21 CFR 870.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971753 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123033: Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B, Rocket Medical Plc (2013) Summary page 5.
- K152105: Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set, Rocket Medical Plc (2016) Summary page 5.

## Indications for use
The Rocket IPC Platinum Cured Catheter is indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice.

Source page: https://510kreport.com/device/K210509
Methodology: https://510kreport.com/methodology