# K173614: Penumbra Coil 400, Ruby Coil System, POD System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Apr 17, 2018 after 146 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: 10 generations back to K951256 (1995). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120330: Penumbra Coil System/Penumbra Coil 400, Penumbra, Inc. (2012) Summary page 5.

## Most influential descendants
- K250079: Ruby XL System (2025), 0 descendants of its own

## Indications for use
Penumbra Coil 400 The Penumbra Coil 400 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. Ruby Coil System Ruby Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. POD System (For POD Coils with nominal sizes ≤ 6 mm) The POD 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. POD System (For POD Coils with nominal sizes > 6 mm) The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K173614
Methodology: https://510kreport.com/methodology