FIQ — Cannula, A-V Shunt Class II
FDA product code FIQ covers "Cannula, A-V Shunt", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FIQ
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K892887 | akcess medical products | ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA | May 15, 1989 |
| K892666 | akcess medical products | SAF-T-SHUNT, S-300 SERIES | May 4, 1989 |
| K892663 | akcess medical products | S-100 ALLEN-BROWN SHUNT | May 4, 1989 |
| K844692 | quinton | PEDIATRIC SIZED HEMOCATH CATHETER | January 18, 1985 |
| K841791 | hospal medical | PLUME FISTULA NEEDLE | July 9, 1984 |
| K840322 | vas-cath of canada | HEMOFILTRATION CATHETER HF-100 | April 24, 1984 |
| K840415 | quinton | HEMOCATH | April 20, 1984 |
| K834358 | vas-cath of canada | PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA | April 2, 1984 |
| K840436 | renal systems | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | February 21, 1984 |
| K833622 | renal systems | RENALLOY HEMASITE VASCULAR ACCESS SHUNT | November 29, 1983 |
| K831801 | exo | HEMOCLAV VENOUS CATHETER | July 7, 1983 |
| K831401 | med-west | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | June 3, 1983 |
| K831440 | med-west | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | June 3, 1983 |
| K823752 | extracorporeal medical specialities | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT | January 14, 1983 |
| K822880 | renal systems | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS | October 18, 1982 |
| K813237 | renal systems | HEMASITE VASCULAR ACCESS SHUNT HM-1000 | November 30, 1981 |
| K812890 | renal systems | HEMASITE GRAFTLESS VASCULAR ACESS | November 16, 1981 |
| K811384 | renal systems | HEMASITE VASCULAR ACCESS SHUNT | July 31, 1981 |
| K810114 | bentley laboratories | VASCULAR ACCESS SYSTEM | March 26, 1981 |
| K801478 | sorensen research | SSC8 SORENSON SUBCLAVIAN CATHETER | August 27, 1980 |