510(k) · Cleared

Cleared

Core and Coil Assembly Guidewire

K970994510(k) TraditionalCleared Mar 25, 19976-day reviewClass I21 CFR 876.5130

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

Lake Region Mfg., Inc. · EZB Stylet For Catheter, Gastro-Urology

Cleared on Mar 25, 1997 after a 6-day review. The FDA summary names its predicate without a number. 5 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.

Decided: Mar 25, 1997
Review: 6 days
Class: Class I
Product code: EZB
Recalls: None
Predicates: 0

21 later devices descend from it, 2 citing it directly. 5 of the 22 devices in this family, counting this one, have a Class I recall.

This deviceK970994 Core and Coil Assembly GuidewireLake Region Mfg., Inc. · 1997
Descendant · cites it directly · 17 of its ownK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
Descendant · 2 generations on · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
Descendant · 3 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
Descendant · 4 generations on · 12 of its ownK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
Descendant · 4 generations on · 11 of its ownK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1998high 2 (2009) · low 0 (1999)2026

Class I recalls in this family

K063525 Datascope Fiber Optic Pressure Sensor…4 generations on · 2007
K112372 Cardiosave Hybrid Intra-Aortic Balloon Pump5 generations on · 2011
K181122 CARDIOSAVE Intra-Aortic Balloon Pump6 generations on · 2018
K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump6 generations on · 2015

Most influential descendants

Showing 5 of 21 · See all

K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp. · 1998 · cites it directly17descendants
K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp. · 2000 · 2 generations on15descendants
K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp. · 2001 · 3 generations on14descendants
K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003 · 4 generations on12descendants
K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970994	Core and Coil Assembly Guidewire	Lake Region Mfg., Inc.	1997	—
+1	K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…	Datascope Corp.	1998	—
+2	K994157	Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…	Datascope Corp.	2000	—
+3	K013326	Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…	Datascope Corp.	2001	—
+4	K031569	Datascope CA 40 8FR. Iabs, Model 0684-00-04XX	Datascope Corp.	2003	—
+4	K041281	Datascope 7.5FR. Iab Catheter and Accessories	Datascope Corp.	2004	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2007	1	1
2008	1	0
2009	2	0
2011	2	1
2012	1	0
2013	1	0
2014	2	0
2015	1	1
2017	2	1
2018	1	1

FIG. 1 — Lineage of K970994, 1997–2018Source: 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.

5 devices in this family have a Class I recall. 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

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
*	—	Flexmedics guidewires Named without a submission number			—

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…	Datascope Corp.	1998	17
K080508	Mandrel Guidewires or M-Wire	Lake Region Medical	2008	2

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls

What does this lineage say?

Of its descendants, K980385 (Datascope Corp., 1998) has gone furthest, with 17 descendants of its own.

How does its category compare?

All EZB devices

EZB Stylet For Catheter, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZB

FDA has decided no EZB device since 2007.

Median 510(k) review, days · EZB

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

Recalls per year · EZB

1in 2007

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · EZB

150in 2025

2007high 410 (2009) · low 33 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	33
2008	—	0	143
2009	—	0	410
2010	—	0	139
2011	—	0	128
2012	—	0	109
2013	—	0	160
2014	—	0	215
2015	—	0	53
2016	—	0	74
2017	—	0	58
2018	—	0	46
2019	—	0	65
2020	—	0	65
2021	—	0	69
2022	—	0	103
2023	—	0	178
2024	—	0	133
2025	—	0	150
2026	—	0	—

https://510kreport.com/device/K970994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970994: Core and Coil Assembly Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970994

Report an extraction error

Are you the manufacturer?

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