Product code KNZ— Gastroenterology, Urology

FDA has cleared 10 devices under product code KNZ between 1983 and 1985, filed by 8 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.

• 19851 clearance
• 19848 clearances
• 19831 clearance

• Renal Systems, Inc.2 clearances
• Medical Components, Inc.2 clearances
• Vas-Cath of Canada , Ltd.1 clearance
• Top Surgical Manufacturers Co.1 clearance
• Quinton, Inc.1 clearance
• Packaging Technologies, Inc.1 clearance
• Intermed, Inc.1 clearance
• Argon Medical Corp.1 clearance

• K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETERArgon Medical Corp.·1985-01-29
• K844612 — ACUTE HEMODIALYSIS TRAYSPackaging Technologies, Inc.·1984-12-17
• K842864 — VACCESS FEMORAL CANNULAVas-Cath of Canada , Ltd.·1984-08-08
• K842416 — DUO FLOW CATHETER-MC 54Medical Components, Inc.·1984-07-26
• K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORALMedical Components, Inc.·1984-06-25
• K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSISTop Surgical Manufacturers Co.·1984-04-20
• K840424 — HEMOCATH REPAIR KITQuinton, Inc.·1984-03-05
• K840437 — HEMASITE ACCESSORIES MODIFICATIONRenal Systems, Inc.·1984-02-21
• K834510 — RENAFLO AVF SET FOR HEMODIALYSISRenal Systems, Inc.·1984-02-04
• K833139 — ACUTE HEMODIALYSIS TRAYSIntermed, Inc.·1983-12-22