510(k) · Cleared

Cleared

Advance 14LP Low Profile PTA Balloon Dilatation Catheter

K170193510(k) SpecialCleared Feb 13, 201721-day reviewClass II21 CFR 870.1250

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

Cook Incorporated · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Feb 13, 2017 as substantially equivalent to K090822 (Cook, Inc., 2009) after a 21-day review. Its family tree reaches back 1 generation to 2009.

Decided: Feb 13, 2017
Review: 21 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K090822 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK090822 Advance 14RX Rapid Exchange Pta Balloon CatheterCook, Inc. · 2009
This deviceK170193 Advance 14LP Low Profile PTA Balloon Dilatation CatheterCook Incorporated · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K090822	Advance 14RX Rapid Exchange Pta Balloon Catheter	Cook, Inc.	2009	—
0 (this device)	K170193	Advance 14LP Low Profile PTA Balloon Dilatation Catheter	Cook Incorporated	2017	—

FIG. 1 — Lineage of K170193, 2009–2017Source: 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 LIT? 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 LIT device

#1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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
*	K090822	Advance 14RX Rapid Exchange Pta Balloon Catheter Summary page 4 …e device, subject of this submission, is substantially equivalent to the predicate device, the Advance® 14Rx Rapid Exchange Balloon Catheter, cleared under 510(k) number K090822. The reference device, K130293, the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter has been included in this submissio…	Cook, Inc.	2009	—
†	K130293	Advance 18LP Low Profile Pta Balloon Dilatation Catheter	Cook, Inc.	2013	—

Also cleared against K090822: 2 other devices →

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?

Its one ancestor has no recall.
2 other devices also cite its predicate K090822.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

What is it indicated for?

The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170193 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170193: Advance 14LP Low Profile PTA Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170193

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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