Product Code: FIQ FDA class 2 21 CFR 876.5540

Cannula, A-V Shunt

Gastroenterology, Urology

The A-V Shunt Cannula is an implanted cannula placed in a patient's arteriovenous shunt or fistula to provide repeated vascular access for hemodialysis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FIQ, regulated under 21 CFR 876.5540, within the Gastroenterology, Urology specialty. This device is intended for implantation.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: FIQ
Device Class: FDA class 2
Regulation Number: 876.5540
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K892887	ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA	May 15, 1989	Substantially Equivalent	Akcess Medical Products, Inc.
K892666	SAF-T-SHUNT, S-300 SERIES	May 04, 1989	Substantially Equivalent	Akcess Medical Products, Inc.
K892663	S-100 ALLEN-BROWN SHUNT	May 04, 1989	Substantially Equivalent	Akcess Medical Products, Inc.
K844692	PEDIATRIC SIZED HEMOCATH CATHETER	Jan 18, 1985	Substantially Equivalent	Quinton, Inc.
K841791	PLUME FISTULA NEEDLE	Jul 09, 1984	Substantially Equivalent	Hospal Medical Corp.
K840322	HEMOFILTRATION CATHETER HF-100	Apr 24, 1984	Substantially Equivalent	Vas-Cath of Canada , Ltd.
K840415	HEMOCATH	Apr 20, 1984	Substantially Equivalent	Quinton, Inc.
K834358	PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA	Apr 02, 1984	Substantially Equivalent	Vas-Cath of Canada , Ltd.
K840436	HEMASITE/RENALOY -VASCULAR ACCESS SHUNT	Feb 21, 1984	Substantially Equivalent	Renal Systems, Inc.
K833622	RENALLOY HEMASITE VASCULAR ACCESS SHUNT	Nov 29, 1983	Substantially Equivalent	Renal Systems, Inc.
K831801	HEMOCLAV VENOUS CATHETER	Jul 07, 1983	Substantially Equivalent	Exo, Inc.
K831440	SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260	Jun 03, 1983	Substantially Equivalent	Med-West, Inc.
K831401	SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS	Jun 03, 1983	Substantially Equivalent	Med-West, Inc.
K823752	EXTRACORPOREAL SUBCLAVIAN CATHETER KIT	Jan 14, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K822880	ARTERIO VENOUS SHUNT CANNULA & ADAPTORS	Oct 18, 1982	Substantially Equivalent	Renal Systems, Inc.
K813237	HEMASITE VASCULAR ACCESS SHUNT HM-1000	Nov 30, 1981	Substantially Equivalent	Renal Systems, Inc.
K812890	HEMASITE GRAFTLESS VASCULAR ACESS	Nov 16, 1981	Substantially Equivalent	Renal Systems, Inc.
K811384	HEMASITE VASCULAR ACCESS SHUNT	Jul 31, 1981	Substantially Equivalent	Renal Systems, Inc.
K810114	VASCULAR ACCESS SYSTEM	Mar 26, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K801478	SSC8 SORENSON SUBCLAVIAN CATHETER	Aug 27, 1980	Substantially Equivalent	Sorensen Research
K791308	ULDALL SUBCLAVIAN CANNULA SC-100	Aug 03, 1979	Substantially Equivalent	Vas-Cath of Canada , Ltd.
K780484	SILASTIC BRAND PENILE IMPLANT	Jul 17, 1978	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K760973	HEMODIALYSIS CANNULA & FEMORAL CLAMP	Jan 12, 1977	Substantially Equivalent	Rodell Medical, Inc.