# K230284: Penumbra LP Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Oct 25, 2023 after 265 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K951256 (1995). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192955: Penumbra LP Coil System, Penumbra, Inc. (2019) Summary page 5.

## Indications for use
The Penumbra LP Coil System is indicated for the embolization of: • Intracranial aneurysms • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae • Arterial and venous embolizations in the peripheral vasculature

Source page: https://510kreport.com/device/K230284
Methodology: https://510kreport.com/methodology