510(k) K911215

GESCO PER-Q-CATH NEEDLE by Gesco Intl., Inc. — Product Code LIT

K911215 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "GESCO PER-Q-CATH NEEDLE". The FDA issued a decision of Substantially Equivalent on June 6, 1991. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.