510(k) Report

FDA applicant

Boston Scientific - Precision Vascular

West Valley City, UT3 decisions2005–200620 recalls

FDA records 3 decisions for Boston Scientific - Precision Vascular (West Valley City, UT) from 2005 to 2006: 3 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and KRA (Catheter, Continuous Flush). Its devices cite 9 predicates, 1 of them its own earlier devices. 20 recalls are 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 - Precision Vascular’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boston Scientific - Precision Vascular since 2007.

Recalls per year

1in 2024

2010: 182024: 1
2007high 18 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Boston”

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