510(k) Report

FDA applicant

Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard

San Clemente, CA2 decisions1992–19930 recalls

FDA records 2 decisions for Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard (San Clemente, CA) from 1992 to 1993: 2 510(k) clearances. All are in product code DQX (Wire, Guide, Catheter). 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 Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard 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?

  • DQXWire, Guide, Catheter2decisions

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.

  • K924009Intravascular Guide Wire and Extension WirePilot Cardiovascular Systems, Inc., Sub. C.R. Bard · 19921cites it
  • K934474Pilot Cardiovascular Systems 2 CM Pilot WirePilot Cardiovascular Systems, Inc., Sub. C.R. Bard · 19931cites it

What has FDA decided for it lately?

  • K934474Pilot Cardiovascular Systems 2 CM Pilot WirePilot Cardiovascular Systems, Inc., Sub. C.R. Bard · 1993
  • K924009Intravascular Guide Wire and Extension WirePilot Cardiovascular Systems, Inc., Sub. C.R. Bard · 1992

All 2 as Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard →