# K832023: Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bionomy, Inc.
- Decided: Aug 31, 1983 after 79 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
53 later devices descend from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961883: Versa-Cath Arterial Catheter (1997), 52 descendants of its own
- K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems (2004), 51 descendants of its own
- K143563: Infusion Aspiration Catheter System (2015), 35 descendants of its own
- K092623: F.a.S.T. System Sed and CXD (2009), 7 descendants of its own
- K163549: ClotTriever Thrombectomy System (2017), 6 descendants of its own

Source page: https://510kreport.com/device/K832023
Methodology: https://510kreport.com/methodology