PMA · Approved

Approved

BX Velocity (TM) with Hepacoat (TM) on Raptor (TM) Stent System for Coronary Arteries

P900043/S024PMAApproved Jul 21, 2000164-day reviewClass III

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

Approved on Jul 21, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 164-day review. 4 later devices descend from it.

Decided: Jul 21, 2000
Review: 164 days
Class: Class III
Product code: MAF
Recalls: None

4 later devices descend from it, 2 citing it directly.

This deviceP900043/S024 BX Velocity (TM) with Hepacoat (TM) on Raptor (TM) Stent System for…Cordis Corp. · 2000
Descendant · cites it directly · 3 of its ownK060155 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter…Spire Biomedical, Inc. · 2006 · Recalled
Descendant · 2 generations on · 0 of its ownK073093 Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc. · 2008
Descendant · cites it directly · 0 of its ownK063441 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24…Spire Biomedical, Inc. · 2007 · Recalled
Descendant · 2 generations on · 0 of its ownK063431 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter…Spire Biomedical, Inc. · 2007 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K06015515.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc. · 2006 · cites it directly3descendants
K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24…Spire Biomedical, Inc. · 2008 · 2 generations on0descendants
K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…Spire Biomedical, Inc. · 2007 · cites it directly0descendants
K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28…Spire Biomedical, Inc. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	P900043/S024	BX Velocity (TM) with Hepacoat (TM) on Raptor (TM) Stent System for Coronary…	Cordis Corp.	2000	—
+1	K060155	15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with…	Spire Biomedical, Inc.	2006	47
+2	K073093	Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models…	Spire Biomedical, Inc.	2008	—
+1	K063441	15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28…	Spire Biomedical, Inc.	2007	48
+2	K063431	15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24…	Spire Biomedical, Inc.	2007	48

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2008	1	0

FIG. 1 — Lineage of P900043/S024, 2000–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K060155	15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips	Spire Biomedical, Inc.	2006	3
K063441	15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…	Spire Biomedical, Inc.	2007	0

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?

Of its descendants, K060155 (Spire Biomedical, Inc., 2006) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MAF devices

MAF Stent, Coronary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAF

2in 2025

2007high 77 (2012) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAF

Too few MAF 510(k)s in any year since 2007 to give a median.

Recalls per year · MAF

1in 2019

2007high 5 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAF

111in 2025

2007high 1,568 (2010) · low 111 (2025)2025

MAUDE reports naming product code MAF, 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	34	—	1	1,201
2008	41	—	1	1,288
2009	36	—	5	1,370
2010	55	—	0	1,568
2011	67	—	0	1,233
2012	77	—	0	1,053
2013	41	—	0	1,049
2014	53	—	0	876
2015	22	—	0	664
2016	26	—	0	696
2017	35	—	0	695
2018	32	—	0	675
2019	25	—	1	561
2020	21	—	0	430
2021	13	—	0	329
2022	8	—	0	280
2023	8	—	0	207
2024	3	—	0	219
2025	2	—	0	111
2026	4	—	0	—

https://510kreport.com/device/P900043/S024 · printed Nov 6, 2026

Cite this page

510(k) Report. “P900043/S024: BX Velocity (TM) with Hepacoat (TM) on Raptor (TM) Stent System for Coronary Arteries.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900043/S024

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026