510(k) · Cleared

Cleared

Temporary Limb Salvage Shunt

K070323510(k) TraditionalCleared Feb 15, 200713-day reviewClass II21 CFR 870.4450

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

Cleared on Feb 15, 2007 as substantially equivalent to K062474 (Mcpherson Enterprises, Inc., 2006) and 3 other predicates after a 13-day review. Its family tree reaches back 1 generation to 1999.

Decided: Feb 15, 2007
Review: 13 days
Class: Class II
Product code: DXC
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K992832 (1999). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK992832 Sulzer Vascutek Eptfe Vascular ProsthesisSulzermedica · 1999
This deviceK070323 Temporary Limb Salvage ShuntVascutek, Ltd. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992832	Sulzer Vascutek Eptfe Vascular Prosthesis	Sulzermedica	1999	—
0 (this device)	K070323	Temporary Limb Salvage Shunt	Vascutek, Ltd.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2006	1	0

FIG. 1 — Lineage of K070323, 1999–2007Source: 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 DXC? 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 DXC device

#1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (4)

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
*	K062474	Smithwick Carotid Shunt Summary page 1 …ngdom Device Predicates: McPherson Enterprises Inc. Smithwick Carotic Shunt (K062474) Boston Scientific Corp. Hemashield Platinum Woven Doub…	Mcpherson Enterprises, Inc.	2006	—
*	K052302	Hemashield Platinum Woven Double Velour Taaa Graft Configuration Summary page 1 …Boston Scientific Corp. Hemashield Platinum Woven Double Velour TAAA Graft (K052302) Boston Scientific Corp. Hemashield Platinum Wov…	Boston Scientific Corp	2005	3
*	K021213	Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts Summary page 1 …Boston Scientific Corp. Hemashield Platinum Woven/Microvelour (K021213) Device Description: The Temporary Limb Salvage Shunt is a hybrid of two types of commercially available Vascutek ePTFE vascular…	Boston Scientific Corp	2002	20
*	K992832	Sulzer Vascutek Eptfe Vascular Prosthesis Summary page 1 …Description: The Temporary Limb Salvage Shunt is a hybrid of two types of commercially available Vascutek ePTFE vascular grafts, i.e. Rapidax TM (G060186) and MAXIFLOTM (K992832). A summary of both grafts is detailed below. The Vascutek Rapidax TM graft comprises an internal ePTFE vascular graft and an ext…	Sulzermedica	1999	—

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?

2 of the 4 ancestors have a recall of any class.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DXC

2in 2025

2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007high 215 (2023) · low 29 (2008)2026

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

Recalls per year · DXC

2in 2023

2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DXC

442in 2025

2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, 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	10	52	0	298
2008	3	29	2	302
2009	4	83	2	539
2010	2	—	1	600
2011	6	51	3	691
2012	5	73	0	548
2013	14	89	0	920
2014	4	157	1	494
2015	5	71	0	374
2016	3	91	0	494
2017	3	90	0	416
2018	2	—	0	391
2019	2	—	0	393
2020	3	209	0	404
2021	6	37	0	371
2022	1	—	1	273
2023	4	215	2	674
2024	1	—	0	375
2025	2	—	0	442
2026	4	125	0	—

What is it indicated for?

THIS DEVICE IS INTENDED TO BE USED AS A TEMPORARY BYPASS SHUNT IN LIMB THREATENING TRAUMA CASES WHERE THERE HAS BEEN DAMAGE TO A MAJOR BLOOD VESSEL

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070323 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070323: Temporary Limb Salvage Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070323

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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