FDA applicant
Heart Technology Mfg., Inc.
FDA records 3 decisions for Heart Technology Mfg., Inc. (Redmond, WA) from 1995 to 1996: 3 510(k) clearances. All are in product code MCW (Catheter, Peripheral, Atherectomy). 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 Heart Technology Mfg., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Heart Technology Mfg., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Heart Technology Mfg., 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) ReportOther applicant names beginning “Heart”
FDA records each applicant name separately; these may or may not be the same firm.