FDA applicant
Boston Scientific /International Technologies
FDA records 5 decisions for Boston Scientific /International Technologies (San Diego, CA) from 1994 to 1997: 5 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DYB (Introducer, Catheter). Its devices cite 6 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
How often FDA has decided Boston Scientific /International Technologies’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Boston Scientific /International Technologies since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Boston Scientific /International…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Boston”
FDA records each applicant name separately; these may or may not be the same firm.