510(k) · Cleared

Cleared

Heavy Double Flexible Tipped Wire Guide

K150802510(k) TraditionalCleared May 28, 201563-day reviewClass II21 CFR 870.1330

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

Cook Incorporated · DQX Wire, Guide, Catheter

Cleared on May 28, 2015 as substantially equivalent to K770977 (Lake Region Mfg., Inc., 1977) after a 63-day review. Its family tree reaches back 1 generation to 1977. 2 later devices descend from it.

Decided: May 28, 2015
Review: 63 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K770977 (1977). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
This deviceK150802 Heavy Double Flexible Tipped Wire GuideCook Incorporated · 2015
Descendant · cites it directly · 1 of its ownK171912 Double Flexible Tip Wire GuidesCook Incorporated · 2018 · Recalled
Descendant · 2 generations on · 0 of its ownK181351 Double Flexible Tipped Wire GuidesCook Incorporated · 2018 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K171912Double Flexible Tip Wire GuidesCook Incorporated · 2018 · cites it directly1descendant
K181351Double Flexible Tipped Wire GuidesCook Incorporated · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K770977	Cardiovascular Spring Guides	Lake Region Mfg., Inc.	1977	1
0 (this device)	K150802	Heavy Double Flexible Tipped Wire Guide	Cook Incorporated	2015	—
+1	K171912	Double Flexible Tip Wire Guides	Cook Incorporated	2018	2
+2	K181351	Double Flexible Tipped Wire Guides	Cook Incorporated	2018	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	2	0

FIG. 1 — Lineage of K150802, 1977–2018Source: 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.

Planning a device in DQX? 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 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? (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
*	K770977	Cardiovascular Spring Guides Summary page 4 …gulation: 21 CFR §870.1330 Product Code: DQX Predicate Device: The predicate device is the Cardiovascular Spring Guides (Lake Region Mfg., Inc., K770977). Device Description: The Heavy Double Flexible Tipped Wire Guide is constructed of stainless steel coils surrounding a stainles…	Lake Region Mfg., Inc.	1977	1

Also cleared against K770977: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K171912	Double Flexible Tip Wire Guides	Cook Incorporated	2018	1

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?

Its one ancestor has a recall.
Of its descendants, K171912 (Cook Incorporated, 2018) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K770977.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

The Heavy Double Flexible Tipped Wire Guide is intended to facilitate placement of devices used during diagnostic and interventional procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150802 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150802: Heavy Double Flexible Tipped Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150802

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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