# K980453: Schneider Guider Softip Guiding Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Aug 11, 1998 after 187 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961999 (1996). 1 ancestor in all.
26 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961999: Schneider Guider Softip Guiding Catheters, Boston Scientific Scimed, Inc. (1996) Summary page 1.

## Most influential descendants
- K071226: 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043 (2007), 21 descendants of its own
- K091299: Spectranetics Turbo-Tandem System (2009), 20 descendants of its own
- K094036: Turbo-Tandem System Model 472-110 (2010), 19 descendants of its own
- K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System (2014), 17 descendants of its own
- K181642: B-Laser Atherectomy System (2018), 8 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.
- Oct 6, 2009 · Not classified · Z-0107-2010: Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.
- Jul 11, 2007 · Not classified · Z-0260-2008: Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)
- Jul 11, 2007 · Not classified · Z-0259-2008: Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)

## Indications for use
The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.

Source page: https://510kreport.com/device/K980453
Methodology: https://510kreport.com/methodology