Product code FIR— Gastroenterology, Urology

FDA has cleared 7 devices under product code FIR between 1976 and 1996, filed by 7 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.

• 19961 clearance
• 19832 clearances
• 19821 clearance
• 19781 clearance
• 19771 clearance
• 19761 clearance

• Renal Systems, Inc.1 clearance
• Parker Hannifin Corp.1 clearance
• Extracorporeal Medical Specialities, Inc.1 clearance
• Dws, Inc.1 clearance
• Cryosan, Inc.1 clearance
• Apheresis Technologies, Inc.1 clearance
• 3M Health Care, Sarns1 clearance

• K961137 — ATI PLASMA PUMP (PP-04)Apheresis Technologies, Inc.·1996-06-14
• K831953 — INFUSION PUMPCryosan, Inc.·1983-07-19
• K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A &Parker Hannifin Corp.·1983-04-12
• K821139 — SPS-SINGLE PATIENT SYSTEMExtracorporeal Medical Specialities, Inc.·1982-05-10
• K780410 — BLOOD PUMP-MODE S10K3M Health Care, Sarns·1978-05-03
• K771705 — RS-7800 MINIPUMPRenal Systems, Inc.·1977-10-04
• K761050 — HEPARIN PUMPDws, Inc.·1976-12-30