510(k) K832787

ELECATH HEPARIN COATED THERMAL DILUTION by Electro-Catheter Corp. — Product Code KYG

K832787 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH HEPARIN COATED THERMAL DILUTION". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.