# K020634: Modification to Atrium Medical Corporation Clearway Ptfe Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: May 8, 2002 after 70 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.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own
- K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 (2006), 9 descendants of its own
- K080901: Lbi Embolectomy System (2008), 6 descendants of its own
- K113757: Aspire Max Aspiration Catheter (2012), 5 descendants of its own

## Indications for use
The Atrium ClearWay™ PTFE Balloon Catheter is intended for the removal of fresh, soft emboli and thrombi and for intraluminal irrigation of fluids.

Source page: https://510kreport.com/device/K020634
Methodology: https://510kreport.com/methodology