510(k) K231044

R2P Navicross by Terumo Medical Corporation — Product Code DQY

K231044 is an FDA 510(k) premarket notification submitted by Terumo Medical Corporation for the device "R2P Navicross". The FDA issued a decision of Substantially Equivalent on July 27, 2023. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Terumo Medical Corporation has at least 10 other 510(k) clearances on record.