# K970080: Arrow-Trerotola PTD Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Jul 25, 1997 after 197 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
53 later devices descend from it; 6 cite it directly.
1 of 54 devices in its family (counting itself) has 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

## Most influential descendants
- K041630: Orbital Atherectomy System for Treatment of a-V Shunt Stenosis (2005), 30 descendants of its own
- K071427: Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis (2007), 28 descendants of its own
- K071350: Diamondback 360 Degree Orbital Atherectomy System (2007), 28 descendants of its own
- K072748: Modification to: Diamondback 360 Orbital Atherectomy System (2007), 26 descendants of its own
- K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System (2008), 25 descendants of its own

## Indications for use
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.

Source page: https://510kreport.com/device/K970080
Methodology: https://510kreport.com/methodology