# K972572: Single Lumen Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: American Biomed, Inc.
- Decided: Jan 13, 1998 after 187 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 K881455 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881455: Embolectomy Catheter (Modified), Cathlab Corp. (1988) Summary page 2.
- K905139: Cathlab Silicone Arterial Embolectomy Catheter, Cathlab Corp. (1991) Summary page 2.

## Indications for use
Removing arterial emboli.

Source page: https://510kreport.com/device/K972572
Methodology: https://510kreport.com/methodology