# K011056: Arrow-Trerotola Percutaneous Thrombolytic Device or PTD

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Oct 24, 2001 after 201 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 13 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990829 (1999). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990829: Arrow-Trerotola  Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit with Introducer Sheaths),PT-65, Arrow Intl., Inc. (1999) Summary page 5.

## Most influential descendants
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) (2010), 9 descendants of its own
- K120346: Cleaner Rotational Thrombectomy System (2012), 8 descendants of its own
- K141617: Cleaner Rotational Thrombectomy System (2014), 7 descendants of its own
- K211798: Cleaner Plus Thrombectomy System (2022), 5 descendants of its own
- K223891: Cobra Catheter System (2023), 2 descendants of its own

## Recalls of this device
- Jan 11, 2022 · Class I · Z-0624-2022: The firm received reports indicating PTD tip separation during use.
- Jan 11, 2022 · Class I · Z-0625-2022: The firm received reports indicating PTD tip separation during use.
- Jan 11, 2022 · Class I · Z-0629-2022: The firm received reports indicating PTD tip separation during use.
- Jan 11, 2022 · Class I · Z-0623-2022: The firm received reports indicating PTD tip separation during use.
- Jan 11, 2022 · Class I · Z-0626-2022: The firm received reports indicating PTD tip separation during use.
- Jan 11, 2022 · Class I · Z-0627-2022: The firm received reports indicating PTD tip separation during use.
- Jan 11, 2022 · Class I · Z-0628-2022: The firm received reports indicating PTD tip separation during use.
- Sep 20, 2021 · Class I · Z-0233-2022: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Sep 20, 2021 · Class I · Z-0234-2022: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Sep 20, 2021 · Class I · Z-0231-2022: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Sep 20, 2021 · Class I · Z-0232-2022: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Feb 11, 2009 · Not classified · Z-1502-2009: 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.
- Mar 18, 2005 · Not classified · Z-0842-05: The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.

## Indications for use
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.

Source page: https://510kreport.com/device/K011056
Methodology: https://510kreport.com/methodology