# K974335: Embolectomy, Irrigation - Occlusion Balloon Catheter by J-Lloyd Medical, Inc.

- Pathway: 510(k) (Traditional)
- Applicant: J-Lloyd Medical, Inc.
- Decided: Feb 13, 1998 after 87 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
Longest line of descent: 1 generation back to K920871 (1993). 2 ancestors in all.
52 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935405: Arterial Embolectomy, J-Lloyd Medical, Inc. (1994) Summary page 1.
- K920871: J-Lloyd Arterial Embolectomy Catheter, J-Lloyd Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- 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
- K162970: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator (2016), 6 descendants of its own

## Indications for use
This catheter is inrended for: 1. Temporarily occlude blood vessel. 2. Irrigating facility for heparin or contrast media. 3. USed for the non-surgical removal of emboli and thrombi,

Source page: https://510kreport.com/device/K974335
Methodology: https://510kreport.com/methodology