# K960372: Scanlan Heifetz Aneurysm Elgiloy Clip System

- Pathway: 510(k) (Traditional)
- Applicant: Scanlan Intl., Inc.
- Decided: Apr 26, 1996 after 91 days
- Product code: HCH (Clip, Aneurysm)
- Device class: 2
- Regulation: 21 CFR 882.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790413 (1979). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790413: Heifetz Aneurysm Clip, LMM Blade, Edward Weck, Inc. (1979) Summary page 1.

## Indications for use
SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting

Source page: https://510kreport.com/device/K960372
Methodology: https://510kreport.com/methodology