Product code FIF— Gastroenterology, Urology

FDA has cleared 6 devices under product code FIF between 1977 and 1987, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19871 clearance
• 19821 clearance
• 19802 clearances
• 19791 clearance
• 19771 clearance

• Sorensen Research1 clearance
• Medical Components, Inc.1 clearance
• Extracorporeal Medical Specialities, Inc.1 clearance
• Cobe Laboratories, Inc.1 clearance
• Cd Medical, Inc.1 clearance
• Cardio Med Supplies, Inc.1 clearance

• K873279 — 8810 PUMP-PUMP SINGLE NEEDLE DEVICECd Medical, Inc.·1987-10-23
• K820173 — COBE SINGLE-NEEDLE CONTROLLER #18-756Cobe Laboratories, Inc.·1982-03-23
• K802230 — BELLCO SINGLE NEEDLE DOUBLE HEAD PUMPCardio Med Supplies, Inc.·1980-12-22
• K801967 — MEDCOMP FEMORAL VEIN CATHETERMedical Components, Inc.·1980-09-26
• K792174 — MODEL DM 353 & DM-353-L SINGLE NEEDLEExtracorporeal Medical Specialities, Inc.·1979-11-16
• K772147 — GW 35 GUIDE WIRESorensen Research·1977-11-28