510(k) Report

510(k) · Cleared

Cleared

Safe-Cross Deflecting Catheter, Model C118ND1

K040481510(k) SpecialCleared Mar 18, 200422-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

Intra Luminal Therapeutics, Inc. · DQY Catheter, Percutaneous

Cleared on Mar 18, 2004 as substantially equivalent to K032784 (Intra Luminal Therapeutics, Inc., 2003) after a 22-day review. Its family tree reaches back 3 generations to 2001. 26 later devices descend from it.

Decided
Mar 18, 2004
Review
22 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K010531 (2001). 26 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2014: 2 descendants cleared2008: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2019: 5 descendants cleared2015: 4 descendants cleared2013: 2 descendants cleared2016: 3 descendants cleared2024: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2023: 1 descendant clearedK010531 · Ilt Deflecting Catheter, Model C114ND1 · Intra Luminal Therapeutics, Inc. · 2001×2: 2 generations cleared close together, K031692 (2003), K032784 (2003) 200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants5 generations forward: 8 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K032784 · Ilt Safe-Cross Deflecting Catheter, Model C114ND1 · Intra Luminal Therapeutics, Inc. · 2003K031692 · Safe-Cross Deflecting Catheter, Model C114ND1 · Intra Luminal Therapeutics, Inc. · 2003K010531 · Ilt Deflecting Catheter, Model C114ND1 · Intra Luminal Therapeutics, Inc. · 20010+5
  1. Root · 3 generations backK010531 Ilt Deflecting Catheter, Model C114ND1Intra Luminal Therapeutics, Inc. · 2001
  2. 2 generations backK031692 Safe-Cross Deflecting Catheter, Model C114ND1Intra Luminal Therapeutics, Inc. · 2003
  3. 1 generation backK032784 Ilt Safe-Cross Deflecting Catheter, Model C114ND1Intra Luminal Therapeutics, Inc. · 2003
  4. This deviceK040481 Safe-Cross Deflecting Catheter, Model C118ND1Intra Luminal Therapeutics, Inc. · 2004
  5. Descendant · cites it directly · 25 of its ownK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
  6. Descendant · 2 generations on · 13 of its ownK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
  7. Descendant · 2 generations on · 10 of its ownK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
  8. Descendant · 3 generations on · 8 of its ownK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
  9. Descendant · 4 generations on · 7 of its ownK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12011: 22012: 12013: 22014: 22015: 42016: 32017: 12018: 22019: 52023: 12024: 1
2006high 5 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 26 · See all
  • K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006 · cites it directly25descendants
  • K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008 · 2 generations on13descendants
  • K132474Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014 · 2 generations on10descendants
  • K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012 · 3 generations on8descendants
  • K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K010531Ilt Deflecting Catheter, Model C114ND1Intra Luminal Therapeutics, Inc.2001—
−2K031692Safe-Cross Deflecting Catheter, Model C114ND1Intra Luminal Therapeutics, Inc.2003—
−1K032784Ilt Safe-Cross Deflecting Catheter, Model C114ND1Intra Luminal Therapeutics, Inc.2003—
0 (this device)K040481Safe-Cross Deflecting Catheter, Model C118ND1Intra Luminal Therapeutics, Inc.2004—
+1K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB2006—
+2K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB2008—
+2K132474Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems2014—
+3K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical2012—
+4K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201120
201210
201320
201420
201540
201630
201710
201820
201950
202310
202410
FIG. 1 — Lineage of K040481, 2001–2024Source: 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
*K032784Ilt Safe-Cross Deflecting Catheter, Model C114ND1
Summary page 1
…ICATE DEVICE The predicate device is the 0.014" Safe-Cross Deflecting Catheter, manufactured by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K032784. DEVICE DESCRIPTION The 0.018" Safe-Cross Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hy…
Intra Luminal Therapeutics, Inc.2003—

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB200625

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?

  • The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 4 months on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K062769 (Radi Medical Systems AB, 2006) has gone furthest, with 25 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 ILT Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guide wire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Indications for use as stated in the FDA summary.

More from Intra Luminal Therapeutics, Inc.

20 FDA decisions under this applicant name. See the company

  • K050916Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]Intra Luminal Therapeutics, Inc. · 2005
  • K050915Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]Intra Luminal Therapeutics, Inc. · 2005
  • K041973Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
  • K040037Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
  • K033929Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K040481 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040481: Safe-Cross Deflecting Catheter, Model C118ND1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040481

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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