# K902327: Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Clincal Instruments Corp.
- Decided: Feb 25, 1991 after 277 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 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
- K033793: Cleaner II Rotational Thrombectomy System (2003), 12 descendants of its own
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) (2010), 9 descendants of its own
- K120346: Cleaner Rotational Thrombectomy System (2012), 8 descendants of its own

## Recalls of this device
- Jul 7, 2016 · Class II · Z-2911-2016: Arrow is recalling due to incorrect labeling of products.
- Mar 25, 2009 · Not classified · Z-1472-2009: The inflation arm tubing may separate from the stopcock adapter.
- Mar 25, 2009 · Not classified · Z-1471-2009: The inflation arm tubing may separate from the stopcock adapter.
- Mar 25, 2009 · Not classified · Z-1473-2009: The inflation arm tubing may separate from the stopcock adapter.

Source page: https://510kreport.com/device/K902327
Methodology: https://510kreport.com/methodology