# K163701: Direxion and Direxion HI-FLO Torqueable Microcatheters

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: May 16, 2017 after 138 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 41 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000177 (2000). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142259: Direxion Torqueable Microcatheter, Boston Scientific Corp (2014) Summary page 4.

## Most influential descendants
- K201792: TRUSELECT Microcatheter (2020), 1 descendant of its own
- K260771: TruSelect™ 2.6 Microcatheter (2026), 0 descendants of its own
- K231821: XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) (2023), 0 descendants of its own

## Recalls of this device
- Sep 16, 2026 · Class II · Z-0224-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0249-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0232-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0255-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0227-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0245-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0258-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0259-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0231-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0250-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0229-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0260-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0263-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0243-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0241-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0226-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0251-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0248-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0262-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0234-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0254-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0230-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0252-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0246-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0253-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0261-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0247-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0225-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0237-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0242-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0238-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0228-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0233-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0244-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0240-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0256-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0236-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0239-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0223-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0235-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves
- Sep 16, 2026 · Class II · Z-0257-2027: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves

## Indications for use
The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

Source page: https://510kreport.com/device/K163701
Methodology: https://510kreport.com/methodology