510(k) Report

FDA applicant

Boston Scientific Epi

Santa Clara, CA2 decisions2003–20040 recalls

FDA records 2 decisions for Boston Scientific Epi (Santa Clara, CA) from 2003 to 2004: 2 510(k) clearances. All are in product code NFA (Temporary Coronary Saphenous Vein Bypass Graft…). Its devices cite 3 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 Boston Scientific Epi’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boston Scientific Epi since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Boston Scientific Epi 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?

  • NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 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.

  • K032884Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathBoston Scientific Epi · 20047cite it
  • K023691Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 20034cite it

What has FDA decided for it lately?

  • K032884Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathBoston Scientific Epi · 2004
  • K023691Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003

All 2 as Boston Scientific Epi →

Other applicant names beginning “Boston”

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

Boston Scientific Corp 809Boston Scientific Scimed, Inc. 40Boston Medical Products, Inc. 33Boston Scientific, Target 19Boston Surgical Products, Inc. 17Boston Biomedica, Inc. 12Boston Scientific Neuromodulation 11Boston Pacific Medical, Inc. 11Boston Medical Corp. 8Boston Aesthetics, Inc. 6The Boston Medical Group 5Boston Scientific/Medi-Tech 5