510(k) Report

FDA applicant

Guided Delivery Systems

Santa Clara, CA2 decisions2009–20100 recalls

FDA records 2 decisions for Guided Delivery Systems (Santa Clara, CA) from 2009 to 2010: 2 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 4 predicates, 1 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 Guided Delivery Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Guided Delivery Systems by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter1decision
  • DQYCatheter, Percutaneous1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091367GDS-DCSGuided Delivery Systems · 20091cites it

What has FDA decided for it lately?

  • K100135GDS-DC12Guided Delivery Systems · 2010
  • K091367GDS-DCSGuided Delivery Systems · 2009

All 2 as Guided Delivery Systems →