Hemasite Graftless Vascular Acess
FDA 510(k) K812890 · Renal Systems, Inc.
510(k) numberK812890
Submission
- Device name
- Hemasite Graftless Vascular Acess
- Applicant
- Renal Systems, Inc.
Mchenry, IL, US - Received
- October 15, 1981
- Decision date
- November 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FIQ – Cannula, A-V Shunt
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FIQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K892887 | ST Series Saf-T-Shunts Arteriovenous CannulaFIQ · Traditional | Akcess Medical Products, Inc. | 05/15/1989SE |
| K892666 | Saf-T-Shunt, S-300 SeriesFIQ · Traditional | Akcess Medical Products, Inc. | 05/04/1989SE |
| K892663 | S-100 Allen-Brown ShuntFIQ · Traditional | Akcess Medical Products, Inc. | 05/04/1989SE |
| K844692 | Pediatric Sized Hemocath CatheterFIQ · Traditional | Quinton, Inc. | 01/18/1985SE |
| K841791 | Plume Fistula NeedleFIQ · Traditional | Hospal Medical Corp. | 07/09/1984SE |
| K840322 | Hemofiltration Catheter HF-100FIQ · Traditional | Vas-Cath of Canada , Ltd. | 04/24/1984SE |
| K840415 | HemocathFIQ · Traditional | Quinton, Inc. | 04/20/1984SE |
| K834358 | Parallel Dual Lumen Subclavian CannulaFIQ · Traditional | Vas-Cath of Canada , Ltd. | 04/02/1984SE |
| K840436 | Hemasite/Renaloy -Vascular Access ShuntFIQ · Traditional | Renal Systems, Inc. | 02/21/1984SE |
| K833622 | Renalloy Hemasite Vascular Access ShuntFIQ · Traditional | Renal Systems, Inc. | 11/29/1983SE |
More from Renal Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | 01/05/1998SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | 06/09/1987SE |
| K854011 | Renalfo Hemofilter CavhdKDI · Traditional | 11/05/1985SE |
| K844790 | Renaflo HemoconcentratorKDI · Traditional | 05/23/1985SE |
| K844108 | Renal Systems Peritoneal Access SystemFKX · Traditional | 01/07/1985SE |
| K843963 | Dialysate Concentrate for Hemodialysis-Liquid/PowdFKQ · Traditional | 01/07/1985SE |
| K842258 | RenatronLIF · Traditional | 07/06/1984SE |
| K841543 | Concentrate Conductivity MeterFKQ · Traditional | 05/22/1984SE |
| K840182 | Renapak Concentrate Mixing Sys.FKQ · Traditional | 05/02/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | 02/21/1984SE |
Questions and answers
When was Hemasite Graftless Vascular Acess cleared by the FDA?
Hemasite Graftless Vascular Acess (K812890) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 32 days after the submission was received.
What is the product code of K812890?
The FDA product code is FIQ – Cannula, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.