# K901625: Fogarty Arterial Embolectomy II Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 6, 1990 after 88 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K100842: Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CM (2010), 2 descendants of its own
- K223613: InThrill Thrombectomy System (2023), 1 descendant of its own
- K250421: InThrill™ Thrombectomy System (2025), 0 descendants of its own
- K233619: Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (2024), 0 descendants of its own

## Recalls of this device
- Jul 6, 2017 · Class II · Z-3077-2017: The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.

Source page: https://510kreport.com/device/K901625
Methodology: https://510kreport.com/methodology