510(k) K813606

SILICONE ELASTOMER INFUSION CATHETER by Quest Medical, Inc. — Product Code JCY

K813606 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "SILICONE ELASTOMER INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on January 18, 1982. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.