510(k) Report

510(k) · Cleared

Cleared

Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx

K042538510(k) TraditionalCleared Nov 8, 200449-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

Invatec Innovative Technologies · DQY Catheter, Percutaneous

Cleared on Nov 8, 2004 after a 49-day review. The FDA summary names its predicate without a number. 57 later devices descend from it.

Decided
Nov 8, 2004
Review
49 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

57 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 4 descendants cleared2006: 1 descendant cleared2018: 1 descendant cleared2010: 3 descendants cleared2009: 2 descendants cleared2011: 6 descendants cleared2015: 7 descendants cleared2013: 5 descendants cleared2012: 4 descendants cleared2016: 9 descendants cleared2014: 3 descendants cleared2019: 3 descendants cleared2020: 2 descendants cleared2017: 2 descendants cleared2022: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK042538 Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
  2. Descendant · cites it directly · 53 of its ownK062809 Admiral Xtreme Pta CatheterInvatec Innovative Technologies · 2006
  3. Descendant · 2 generations on · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
  4. Descendant · 3 generations on · 14 of its ownK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled
  5. Descendant · 2 generations on · 12 of its ownK100921 Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A. · 2010
  6. Descendant · 3 generations on · 9 of its ownK103464 Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · Recalled

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2006: 12008: 42009: 22010: 32011: 62012: 42013: 52014: 32015: 72016: 92017: 22018: 12019: 32020: 22021: 12022: 12024: 12025: 12026: 1
2006high 9 (2016) · low 0 (2007)2026

Most influential descendants

Showing 5 of 57 · See all
  • K062809Admiral Xtreme Pta CatheterInvatec Innovative Technologies · 2006 · cites it directly53descendants
  • K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · 2 generations on35descendants
  • K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · 3 generations on14descendants
  • K100921Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A. · 2010 · 2 generations on12descendants
  • K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042538Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model…Invatec Innovative Technologies2004—
+1K062809Admiral Xtreme Pta CatheterInvatec Innovative Technologies2006—
+2K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.20081
+3K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.20092
+2K100921Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A.2010—
+3K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200840
200920
201030
201160
201240
201350
201430
201570
201690
201720
201810
201930
202020
202110
202210
202410
202510
202610
FIG. 1 — Lineage of K042538, 2004–2026Source: 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 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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Cordis OPTA PRO Balloon Dilatation Catheter
Named without a submission number
—

What descends from it? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K062809Admiral Xtreme Pta CatheterInvatec Innovative Technologies200653
K080264Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions20081
K082646Optimus 0.035 Pta Balloon Dilatation CatheterUsci Ireland20080

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, K062809 (Invatec Innovative Technologies, 2006) has gone furthest, with 53 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

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
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

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The SAILOR TM PLUS PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Indications for use as stated in the FDA summary.

More from Invatec Innovative Technologies

3 FDA decisions under this applicant name. See the company

  • K062809Admiral Xtreme Pta CatheterInvatec Innovative Technologies · 2006
  • K042537Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model SuvxxxxxxxxxInvatec Innovative Technologies · 2004

Recent decisions in DQY

The DQY category page

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https://510kreport.com/device/K042538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042538: Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042538

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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