510(k) Report

FDA applicant

Trans Vascular Incorporated

Menlo Park, CA2 decisions2002–20031 recall

FDA records 2 decisions for Trans Vascular Incorporated (Menlo Park, CA) from 2002 to 2003: 2 510(k) clearances. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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, radiology panel, where it files most

How often FDA has decided Trans Vascular Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trans Vascular Incorporated since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Trans Vascular Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K013363Crosspoint Transaccess CatheterTrans Vascular Incorporated · 20022cite it
  • K031920Crosspoint Transaccess Catheter, Model TA-XP-001Trans Vascular Incorporated · 20031cites it

What has FDA decided for it lately?

  • K031920Crosspoint Transaccess Catheter, Model TA-XP-001Trans Vascular Incorporated · 20031 recall
  • K013363Crosspoint Transaccess CatheterTrans Vascular Incorporated · 2002

All 2 as Trans Vascular Incorporated →

What has been recalled?

1 recall linked to its devices; the latest:

  • K031920Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is…Nov 1, 2006

Other applicant names beginning “Trans”

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

Trans World Agency, Inc. 2Trans-National Trade Development Corp. 2Trans Texas Medical Devices Corp. 1Trans-America Enterprises Corp. 1Trans-Med Corp. 1Trans American Chemical Corp. 1Trans-Pacific Healthcare-USA 1Trans Aire 1Trans Ancient Products Co., Ltd. 1Trans-Atlantic Dental 1Trans Pace, Inc. 1