# K990829: Arrow-Trerotola  Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit with Introducer Sheaths),PT-65

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: May 4, 1999 after 53 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 5 cite it directly.
1 of 22 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) Arrow-Trerotola™ Percutaneous Thrombolytic Device or “PTD”: named in the summary without a submission number

## Most influential descendants
- K031610: Rex Medical Cleaner Rotational Thrombectomy System (2003), 13 descendants of its own
- K033793: Cleaner II Rotational Thrombectomy System (2003), 12 descendants of its own
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K011056: Arrow-Trerotola Percutaneous Thrombolytic Device or PTD (2001), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own

## Recalls of this device
- Feb 11, 2009 · Not classified · Z-1501-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

## 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 synthetic dialysis grafts.

Source page: https://510kreport.com/device/K990829
Methodology: https://510kreport.com/methodology