# K143218: Penumbra Smart Coil

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Mar 18, 2015 after 128 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.
4 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103305: Penumbra Embolization Coil System, Penumbra, Inc. (2011) Summary page 5.
- K120330: Penumbra Coil System/Penumbra Coil 400, Penumbra, Inc. (2012) Summary page 5.

## Most influential descendants
- K151572: Penumbra Smart Coil (2015), 3 descendants of its own
- K160832: Penumbra Smart Coil (2016), 2 descendants of its own
- K192955: Penumbra LP Coil System (2019), 1 descendant of its own
- K230284: Penumbra LP Coil System (2023), 0 descendants of its own

## Indications for use
The Smart Coil 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/K143218
Methodology: https://510kreport.com/methodology