510(k) Report

510(k) · Cleared

Cleared

Polar Cath Peripheral Dilatation System

K051916510(k) SpecialCleared Aug 5, 200521-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

Cryo Vascular Systems, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Aug 5, 2005 after a 21-day review. The FDA summary names its predicate without a number. 98 later devices descend from it.

Decided
Aug 5, 2005
Review
21 days
Class
Class II
Product code
LIT
Recalls
None
Predicates
0

98 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2008: 2 descendants cleared2025: 6 descendants cleared2010: 2 descendants cleared2011: 8 descendants cleared2012: 7 descendants cleared2015: 7 descendants cleared2009: 1 descendant cleared2019: 4 descendants cleared2017: 5 descendants cleared2014: 6 descendants cleared2016: 9 descendants cleared2022: 7 descendants cleared2020: 5 descendants cleared2023: 2 descendants cleared2024: 8 descendants cleared2013: 6 descendants cleared2026: 6 descendants cleared2018: 2 descendants cleared2021: 3 descendants cleared20052010201520202025
  1. This deviceK051916 Polar Cath Peripheral Dilatation SystemCryo Vascular Systems, Inc. · 2005
  2. Descendant · cites it directly · 97 of its ownK060572 Modification to Polarcath Peripheral Dilatation SystemBoston Scientific Corporation · 2006
  3. Descendant · 2 generations on · 96 of its ownK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
  5. Descendant · 3 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
  6. Descendant · 3 generations on · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled

Showing 5 of 98 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 22009: 12010: 22011: 82012: 72013: 62014: 62015: 72016: 92017: 52018: 22019: 42020: 52021: 32022: 72023: 22024: 82025: 62026: 6
2006high 9 (2016) · low 1 (2006)2026

Most influential descendants

Showing 5 of 98 · See all
  • K060572Modification to Polarcath Peripheral Dilatation SystemBoston Scientific Corporation · 2006 · cites it directly97descendants
  • K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · 2 generations on96descendants
  • K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 3 generations on44descendants
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 3 generations on36descendants
  • K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · 3 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051916Polar Cath Peripheral Dilatation SystemCryo Vascular Systems, Inc.2005—
+1K060572Modification to Polarcath Peripheral Dilatation SystemBoston Scientific Corporation2006—
+2K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.200715
+3K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.20082
+3K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.2010—
+3K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200820
200910
201020
201180
201270
201360
201460
201570
201690
201750
201820
201940
202050
202130
202270
202320
202480
202560
202660
FIG. 1 — Lineage of K051916, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—PolarCath Peripheral Dilatation System
Named without a submission number
—

What descends from it? (98)

See all 98

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

NumberDeviceApplicantDecidedDescendants
K060572Modification to Polarcath Peripheral Dilatation SystemBoston Scientific Corporation200697

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?

  • Of its descendants, K060572 (Boston Scientific Corporation, 2006) has gone furthest, with 97 descendants of its own.

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.

FDA decisions per year · LIT

3in 2025

2007: 62008: 82009: 72010: 132011: 102012: 192013: 142014: 122015: 192016: 112017: 92018: 62019: 42020: 92021: 42022: 82023: 62024: 62025: 32026 (partial year): 4
2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007: 64 days median2008: 53 days median2009: 29 days median2010: 78 days median2011: 82 days median2012: 29 days median2013: 79 days median2014: 90 days median2015: 112 days median2016: 116 days median2017: 57 days median2018: 118 days median2019: 40 days median2020: 125 days median2021: 61 days median2022: 122 days median2023: 167 days median2024: 43 days median2025: 90 days median2026 (partial year): 205 days median
2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2009: 22010: 12013: 2, 2 Class I2014: 32016: 12018: 22019: 32021: 12024: 22025: 1
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

2007: 5772008: 5132009: 6232010: 8092011: 8572012: 1,2772013: 1,2422014: 1,1782015: 1,2792016: 1,5292017: 2,0812018: 2,1882019: 2,4052020: 2,4432021: 2,4922022: 2,1552023: 1,8072024: 1,9132025: 2,073
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076640577
20088530513
20097292623
201013781809
201110820857
2012192901,277
201314792 (2)1,242
2014129031,178
20151911201,279
20161111611,529
201795702,081
2018611822,188
201944032,405
2020912502,443
202146112,492
2022812202,155
2023616701,807
202464321,913
202539012,073
202642050—

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.

More from Cryo Vascular Systems, Inc.

7 FDA decisions under this applicant name. See the company

  • K042230Polarcath Peripheral Balloon Catheter SystemCryo Vascular Systems, Inc. · 2004
  • K042541Modification to Polarcath Peripheral Dilatation SystemCryo Vascular Systems, Inc. · 2004
  • K033622Polarcath Peripheral Dilatation SystemCryo Vascular Systems, Inc. · 2004
  • K030742Polarcath Peripheral Balloon Catheter SystemCryo Vascular Systems, Inc. · 2003
  • K023463Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation UnitCryo Vascular Systems, Inc. · 2003

Recent decisions in LIT

The LIT category page

  • K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026
  • K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026
  • K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026
  • K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025

https://510kreport.com/device/K051916 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051916: Polar Cath Peripheral Dilatation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051916

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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