510(k) · Cleared

Cleared

Transxchange Support Catheter

K033540510(k) TraditionalCleared May 25, 2004197-day reviewClass II21 CFR 870.1250

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

Medtronic Vascular · DQY Catheter, Percutaneous

Cleared on May 25, 2004 as substantially equivalent to K991059 (Spectranetics Corp., 1999) after a 197-day review. Its family tree reaches back 2 generations to 1994.

Decided: May 25, 2004
Review: 197 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K935425 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
1 generation backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
This deviceK033540 Transxchange Support CatheterMedtronic Vascular · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K935425	Metronic Buchbinder Envoy Percutaneous Catheters	Medtronics Interventional Vascular	1994	—
−1	K991059	Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018…	Spectranetics Corp.	1999	—
0 (this device)	K033540	Transxchange Support Catheter	Medtronic Vascular	2004	—

FIG. 1 — Lineage of K033540, 1994–2004Source: 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
*	K991059	Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support… Summary page 1 …870-1250) 3. Predicate Device Information: Name: Spectranetics Support Catheter Manufacturer: Spectranetics 510(k) Number: K991059 Clearance Date: October 19, 1999 4. Device Description The TransXchange Support Catheter is des…	Spectranetics Corp.	1999	—

Also cleared against K991059: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
None of the 2 ancestors has a recall.
6 other devices also cite its predicate K991059.

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 TransXchange Support Catheter is a guidewire exchange and infusion device designed for use in the peripheral vascular system. The catheter is intended to support a guidewire during access of vessels, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033540 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033540: Transxchange Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033540

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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