510(k) · Cleared

Recalled · Class II · 2022

Schneider Guider Softip Guiding Catheters

K980453510(k) TraditionalCleared Aug 11, 1998187-day reviewClass II21 CFR 870.1250Recalls 20

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Scimed, Inc. · DQY Catheter, Percutaneous

Cleared on Aug 11, 1998 as substantially equivalent to K961999 (Boston Scientific Scimed, Inc., 1996) after a 187-day review. Its family tree reaches back 1 generation to 1996. 26 later devices descend from it. It has been recalled 20 times.

Decided: Aug 11, 1998
Review: 187 days
Class: Class II
Product code: DQY
Recalls: 20
Predicates: 1

Its longest line of descent runs back 1 generation to K961999 (1996). 26 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK961999 Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. · 1996
This deviceK980453 Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. · 1998
Descendant · cites it directly · 21 of its ownK071226 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063…Spectranetics Corp. · 2007 · Recalled
Descendant · 2 generations on · 20 of its ownK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
Descendant · 3 generations on · 19 of its ownK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
Descendant · 3 generations on · 17 of its ownK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
Descendant · 4 generations on · 8 of its ownK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2007high 5 (2022) · low 0 (2008)2026

Most influential descendants

Showing 5 of 26 · See all

K0712268FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043Spectranetics Corp. · 2007 · cites it directly21descendants
K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009 · 2 generations on20descendants
K094036Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010 · 3 generations on19descendants
K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · 3 generations on17descendants
K181642B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018 · 4 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961999	Schneider Guider Softip Guiding Catheters	Boston Scientific Scimed, Inc.	1996	—
0 (this device)	K980453	Schneider Guider Softip Guiding Catheters	Boston Scientific Scimed, Inc.	1998	—
+1	K071226	8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043	Spectranetics Corp.	2007	2
+2	K091299	Spectranetics Turbo-Tandem System	Spectranetics Corp.	2009	—
+3	K094036	Turbo-Tandem System Model 472-110	Spectranetics Corp.	2010	—
+3	K140775	Turbo-Elite Atherectomy Catheters, Turbo Tandem System	Spectranetics Corporation	2014	3
+4	K181642	B-Laser Atherectomy System	Eximo Medical, Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2013	1	0
2014	1	0
2015	2	0
2017	3	0
2018	2	0
2020	1	0
2021	1	0
2022	5	0
2023	2	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K980453, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K961999	Schneider Guider Softip Guiding Catheters Summary page 1 …(612) 550-5771 Ronald W. Bennett Senior Regulatory Affairs Specialist SCHNEIDER GUIDER Softip® Guiding Catheters Class I SCHNEIDER GUIDER Softip® Guiding Catheters (X961999) Cordis Vista brite tip™ guiding catheter The SCHNEIDER GUIDER Softip® Guiding Catheter in this 510(k) is avajlable in four Fren…	Boston Scientific Scimed, Inc.	1996	—

Also cleared against K961999: 1 other device →

What descends from it? (26)

See all 26

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071226	8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043	Spectranetics Corp.	2007	21
K141981	Asahi Fubuki 043 / Asahi Fubuki	Asahi Intecc Co., Ltd.	2015	2
K132542	Transgate Guide Catheter	Stryker Neurovascular	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 9, 2022	Class II	Z-1582-2022	Process control	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	Process change control	Potential polymer material degradation.
Oct 5, 2016	Class II	Z-0338-2017	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Employee error	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	Environmental control	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	Labeling mix-ups	Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)
Jul 11, 2007	Not classified	Z-0259-2008	Labeling mix-ups	Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)

The 5 latest of 20 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K071226 (Spectranetics Corp., 2007) has gone furthest, with 21 descendants of its own.
1 other device also cites its predicate K961999.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980453 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980453: Schneider Guider Softip Guiding Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980453

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026