510(k) · Cleared

Cleared

X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1

K002054510(k) TraditionalCleared Feb 16, 2001225-day reviewClass II21 CFR 870.1340

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

Appriva Medical, Inc. · DYB Introducer, Catheter

Cleared on Feb 16, 2001 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided: Feb 16, 2001
Review: 225 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 0

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

This deviceK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
Descendant · cites it directly · 10 of its ownK012489 Modification to: X-Sept Transseptal Shealth and Transition Catheter…Appriva Medical, Inc. · 2001
Descendant · 2 generations on · 9 of its ownK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
Descendant · cites it directly · 8 of its ownK083793 Steerable Guide CatheterEvalve, Inc. · 2009
Descendant · 2 generations on · 7 of its ownK091596 Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
Descendant · 2 generations on · 6 of its ownK093866 Evalve Steerable Guide CatheterEvalve, Inc. · 2010

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2001high 2 (2009) · low 0 (2002)2026

Most influential descendants

Showing 5 of 11 · See all

K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator)…Appriva Medical, Inc. · 2001 · cites it directly10descendants
K043084Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005 · 2 generations on9descendants
K083793Steerable Guide CatheterEvalve, Inc. · 2009 · cites it directly8descendants
K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009 · 2 generations on7descendants
K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002054	X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90…	Appriva Medical, Inc.	2001	—
+1	K012489	Modification to: X-Sept Transseptal Shealth and Transition Catheter (with…	Appriva Medical, Inc.	2001	—
+2	K043084	Premere Delivery Sheath, Model PDS	Velocimed, Inc.	2005	—
+1	K083793	Steerable Guide Catheter	Evalve, Inc.	2009	—
+2	K091596	Evalve Steerable Guide Catheter, Model SGC01ST	Evalve, Inc.	2009	—
+2	K093866	Evalve Steerable Guide Catheter	Evalve, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	1	0
2009	2	0
2010	2	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2016	1	0

FIG. 1 — Lineage of K002054, 2001–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in DYB? 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 DYB device

#1 K251051 AuST Steerable Sheathscore 18.0 · 10 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K012489	Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator)…	Appriva Medical, Inc.	2001	10
K083793	Steerable Guide Catheter	Evalve, Inc.	2009	8

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, K012489 (Appriva Medical, Inc., 2001) has gone furthest, with 10 descendants of its own.

How does its category compare?

All DYB devices

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

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

https://510kreport.com/device/K002054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002054: X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002054

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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