510(k) K790444

ELECATH MULTI-PURPOSE ARTERIAL SURGER by Electro-Catheter Corp. — Product Code GBA

K790444 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH MULTI-PURPOSE ARTERIAL SURGER". The FDA issued a decision of Substantially Equivalent on June 11, 1979. The device falls under product code GBA (Catheter, Balloon Type), a Class I device regulated under 21 CFR 878.4200. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.