# K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 20, 1989 after 104 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- 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; 6 cite 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
- K143563: Infusion Aspiration Catheter System (2015), 35 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
- K110315: Nexgen Peripheral Mechanical Retrieval Device (2011), 6 descendants of its own
- K080901: Lbi Embolectomy System (2008), 6 descendants of its own

## Recalls of this device
- Sep 7, 2023 · Class II · Z-0238-2024: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Source page: https://510kreport.com/device/K892410
Methodology: https://510kreport.com/methodology