# K010853: Guider Softip Guiding Catheter XF 5F

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific, Target
- Decided: Apr 18, 2001 after 28 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
108 later devices descend from it; 3 cite it directly.
4 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070970: Neuron Support Catheter System, Model 5F/6F (2007), 105 descendants of its own
- K082290: Neuron Delivery Catheter 070 (2008), 88 descendants of its own
- K083125: Neuron Select Catheter Size 070 (2008), 86 descendants of its own
- K111380: Neuron Max System (2011), 61 descendants of its own
- K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length (2018), 27 descendants of its own

## Recalls of this device
- Aug 9, 2022 · Class II · Z-1582-2022: The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
- Dec 11, 2017 · Class II · Z-2735-2018: Potential polymer material degradation.
- Oct 5, 2016 · Class II · Z-0338-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0340-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0341-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0342-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0344-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0337-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0343-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0333-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0335-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0346-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0347-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0334-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0336-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0339-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Oct 5, 2016 · Class II · Z-0345-2017: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.

Source page: https://510kreport.com/device/K010853
Methodology: https://510kreport.com/methodology