# K002627: Atrium Medical Corporation Clearway Ptfe Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Apr 26, 2001 after 246 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K080901: Lbi Embolectomy System (2008), 6 descendants of its own
- K113757: Aspire Max Aspiration Catheter (2012), 5 descendants of its own
- K220780: ROVO Mechanical Thrombectomy Device (2023), 1 descendant of its own
- K200871: Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator (2020), 1 descendant of its own
- K253730: RoVo Mechanical Thrombectomy System (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K002627
Methodology: https://510kreport.com/methodology