Product code FIQ
- Device name
- Cannula, A-V Shunt
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K892887 | ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA | Akcess Medical Products, Inc. | 1989-05-15 |
| K892666 | SAF-T-SHUNT, S-300 SERIES | Akcess Medical Products, Inc. | 1989-05-04 |
| K892663 | S-100 ALLEN-BROWN SHUNT | Akcess Medical Products, Inc. | 1989-05-04 |
| K844692 | PEDIATRIC SIZED HEMOCATH CATHETER | Quinton, Inc. | 1985-01-18 |
| K841791 | PLUME FISTULA NEEDLE | Hospal Medical Corp. | 1984-07-09 |
| K840322 | HEMOFILTRATION CATHETER HF-100 | Vas-Cath of Canada , Ltd. | 1984-04-24 |
| K840415 | HEMOCATH | Quinton, Inc. | 1984-04-20 |
| K834358 | PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA | Vas-Cath of Canada , Ltd. | 1984-04-02 |
| K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1984-02-21 |
| K833622 | RENALLOY HEMASITE VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1983-11-29 |
| K831801 | HEMOCLAV VENOUS CATHETER | Exo, Inc. | 1983-07-07 |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | Med-West, Inc. | 1983-06-03 |
| K831401 | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | Med-West, Inc. | 1983-06-03 |
| K823752 | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT | Extracorporeal Medical Specialities, Inc. | 1983-01-14 |
| K822880 | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS | Renal Systems, Inc. | 1982-10-18 |
| K813237 | HEMASITE VASCULAR ACCESS SHUNT HM-1000 | Renal Systems, Inc. | 1981-11-30 |
| K812890 | HEMASITE GRAFTLESS VASCULAR ACESS | Renal Systems, Inc. | 1981-11-16 |
| K811384 | HEMASITE VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1981-07-31 |
| K810114 | VASCULAR ACCESS SYSTEM | Bentley Laboratories, Inc. | 1981-03-26 |
| K801478 | SSC8 SORENSON SUBCLAVIAN CATHETER | Sorensen Research | 1980-08-27 |
| K791308 | ULDALL SUBCLAVIAN CANNULA SC-100 | Vas-Cath of Canada , Ltd. | 1979-08-03 |
| K780484 | SILASTIC BRAND PENILE IMPLANT | Dow Corning Corp. Healthcare Industries Materials | 1978-07-17 |
| K760973 | HEMODIALYSIS CANNULA & FEMORAL CLAMP | Rodell Medical, Inc. | 1977-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884521009813 | Permcath | Mozarc Medical US LLC | 2014-09-01 |
| 20884521009827 | Permcath | Mozarc Medical US LLC | 2014-09-01 |