FDA applicant
Angioscore, Inc.
FDA records 13 decisions for Angioscore, Inc. (Fremont, CA) from 2005 to 2015: 13 510(k) clearances. All are in product code PNO (Catheter, Percutaneous, Cutting/Scoring). Its devices cite 45 predicates, 34 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Angioscore, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2007high 3 (2008) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
5in 2010
2007high 5 (2010) · low 0 (2007)2026
Class I Class II/III not classified
Planning a device like Angioscore, 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