510(k) Report

FDA applicant

Intra Luminal Therapeutics, Inc.

Carlsbad, CA20 decisions2000–20050 recalls

FDA records 20 decisions for Intra Luminal Therapeutics, Inc. (Carlsbad, CA) from 2000 to 2005: 20 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 24 predicates, 17 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Intra Luminal Therapeutics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intra Luminal Therapeutics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intra Luminal Therapeutics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intra Luminal Therapeutics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQXWire, Guide, Catheter10decisions
  • DQYCatheter, Percutaneous8decisions
  • PDUCatheter For Crossing Total Occlusions2decisions

Whose devices does it build on?

Its devices cite 24 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 17 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K001992Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 20005cite it
  • K031842Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 20033cite it
  • K040037Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 20042cite it
  • K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross Angled Support…Intra Luminal Therapeutics, Inc. · 20032cite it
  • K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism, Model A11AM1Intra Luminal Therapeutics, Inc. · 20012cite it
  • K021323Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 20022cite it

What has FDA decided for it lately?

  • 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
  • K040481Safe-Cross Deflecting Catheter, Model C118ND1Intra 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
  • K032031Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
  • K033708Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003

All 20 as Intra Luminal Therapeutics, Inc. →

Other applicant names beginning “Intra”

FDA records each applicant name separately; these may or may not be the same firm.

Intra-Lock International 13Intra Lase Corp. 9Intra Vantage, Inc. 1Intra Special Catheters GmbH 1Intra-Sonix, Inc. 1Intra-Optics Labs. C/O Newman Assoc. 1