510(k) Report

FDA applicant

Cross Vascular, Inc.

Solana Beach, CA2 decisions2023–20230 recalls

FDA records 2 decisions for Cross Vascular, Inc. (Solana Beach, CA) in 2023: 2 510(k) clearances. Most are in product codes DXF (Catheter, Septostomy) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 predicates, 0 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 Cross Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Cross Vascular, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cross Vascular, 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?

  • DXFCatheter, Septostomy1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 20231cites it
  • K232809Cross Vascular RF Generator and Footswitch (optional accessory)Cross Vascular, Inc. · 20231cites it

What has FDA decided for it lately?

  • K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 2023
  • K232809Cross Vascular RF Generator and Footswitch (optional accessory)Cross Vascular, Inc. · 2023

All 2 as Cross Vascular, Inc. →

Other applicant names beginning “Cross”

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

Cross Medical Products, Inc. 7Cross Country Paper Products Corp. 3Cross Protection (M) Sdn Bhd 1