510(k) K240246

Accusafe Transseptal Guidewire (GTR31180, GTR31230) by Synaptic Medical Corporation — Product Code DRC

K240246 is an FDA 510(k) premarket notification submitted by Synaptic Medical Corporation for the device "Accusafe Transseptal Guidewire (GTR31180, GTR31230)". The FDA issued a decision of Substantially Equivalent on July 26, 2024. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Synaptic Medical Corporation has at least 3 other 510(k) clearances on record.