# K983534: 7F Hydrolyser Thrombectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Feb 26, 1999 after 140 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- 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.
4 later devices descend from it; 1 cites 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. The FDA summary names its predicate without a number.
- (no number) Angiodynamics PRO™ Infusion Catheter: named in the summary without a submission number
- (no number) Arrow-Trerotola™ Percutaneous Thrombolytic Device Catheter: named in the summary without a submission number

## Most influential descendants
- K041705: Resolution Thrombectomy System, Model EV-2 (2004), 3 descendants of its own
- K052428: Resolution Endovascular System (2005), 2 descendants of its own
- K071762: Omniwave Endovascular System (2007), 1 descendant of its own
- K083335: Modified Omniwave Endovascular System (2008), 0 descendants of its own

## Indications for use
The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (< 5 days old) thrombus from dialysis shunts.

Source page: https://510kreport.com/device/K983534
Methodology: https://510kreport.com/methodology