510(k) · Cleared

Cleared

Modification to Polarcath Peripheral Dilatation System

K060572510(k) SpecialCleared Mar 15, 20069-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

Boston Scientific Corporation · DQY Catheter, Percutaneous

Cleared on Mar 15, 2006 as substantially equivalent to K051916 (Cryo Vascular Systems, Inc., 2005) after a 9-day review. Its family tree reaches back 1 generation to 2005. 97 later devices descend from it.

Decided: Mar 15, 2006
Review: 9 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051916 (2005). 97 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK051916 Polar Cath Peripheral Dilatation SystemCryo Vascular Systems, Inc. · 2005
This deviceK060572 Modification to Polarcath Peripheral Dilatation SystemBoston Scientific Corporation · 2006
Descendant · cites it directly · 96 of its ownK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
Descendant · 2 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
Descendant · 2 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
Descendant · 2 generations on · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
Descendant · 3 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2007high 9 (2016) · low 1 (2007)2026

Most influential descendants

Showing 5 of 97 · See all

K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · cites it directly96descendants
K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 2 generations on44descendants
K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 2 generations on36descendants
K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · 2 generations on35descendants
K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 3 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051916	Polar Cath Peripheral Dilatation System	Cryo Vascular Systems, Inc.	2005	—
0 (this device)	K060572	Modification to Polarcath Peripheral Dilatation System	Boston Scientific Corporation	2006	—
+1	K072283	Dorado Pta Balloon Dilatation Catheter	Bard Peripheral Vascular, Inc.	2007	15
+2	K083657	Conquest Pta Balloon Dilatation Catheter	C.R. Bard, Inc.	2008	2
+2	K103459	Vascutrak Pta Dilatation Catheter	C.R. Bard, Inc.	2010	—
+2	K082579	Evercross .035 Otw Pta Dilatation Catheter	Ev3, Inc.	2008	1
+3	K112182	Angiosculpt Pta Scoring Balloon Catheter	Angioscore, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2009	1	0
2010	2	0
2011	8	0
2012	7	0
2013	6	0
2014	6	0
2015	7	0
2016	9	0
2017	5	0
2018	2	0
2019	4	0
2020	5	0
2021	3	0
2022	7	0
2023	2	0
2024	8	0
2025	6	0
2026	6	0

FIG. 1 — Lineage of K060572, 2005–2026Source: 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 DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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
*	K051916	Polar Cath Peripheral Dilatation System Summary page 2 …Class 11 d. Predicate Device Information The predicate device is the PolarCath Peripheral Dilatation System cleared in K051916, SE 8.5.2005. C. Labeling A draft copy of the Instructions for Use (IFU) and labels can be found i…	Cryo Vascular Systems, Inc.	2005	—

What descends from it? (97)

See all 97

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

Number	Device	Applicant	Decided	Descendants
K072283	Dorado Pta Balloon Dilatation Catheter	Bard Peripheral Vascular, Inc.	2007	96

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.
Of its descendants, K072283 (Bard Peripheral Vascular, Inc., 2007) has gone furthest, with 96 descendants of its own.

How does its category compare?

All DQY devices

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

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060572 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060572: Modification to Polarcath Peripheral Dilatation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060572

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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