FDA applicant
Nitinol Medical Technologies, Inc.
FDA records 7 decisions for Nitinol Medical Technologies, Inc. (Boston, MA) from 1990 to 1997: 7 510(k) clearances. All are in product code DTK (Filter, Intravascular, Cardiovascular). Its devices cite 10 predicates, 10 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 Nitinol Medical Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Nitinol Medical Technologies, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Nitinol Medical Technologies, Inc.’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) Report