Product code FJT— Gastroenterology, Urology

FDA has cleared 5 devices under product code FJT between 1976 and 1986, filed by 3 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.

• 19861 clearance
• 19773 clearances
• 19761 clearance

• Sorensen Research3 clearances
• National Medical Care, Medical Products Div., Inc.1 clearance
• Extracorporeal Medical Specialities, Inc.1 clearance

• K863297 — MODIFICATION'S TO TORAY'S B-2 SERIESNational Medical Care, Medical Products Div., Inc.·1986-09-25
• K772146 — CATHETER, VEIN, FEMORAL, SF 10Sorensen Research·1977-11-29
• K772148 — CATHETER, FEMORAL VEIN, SF 6Sorensen Research·1977-11-29
• K770047 — DNC 151 VINCA-FLOSorensen Research·1977-01-14
• K760781 — TRIEX-1 HOLLOW FIBER DIALYZERExtracorporeal Medical Specialities, Inc.·1976-12-06