ST Series Saf-T-Shunts Arteriovenous Cannula
FDA 510(k) K892887 · Akcess Medical Products, Inc.
510(k) numberK892887
Submission
- Device name
- ST Series Saf-T-Shunts Arteriovenous Cannula
- Applicant
- Akcess Medical Products, Inc.
New Brunswick, NJ, US - Received
- April 20, 1989
- Decision date
- May 15, 1989
- 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 |
|---|---|---|---|
| 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 |
| K831801 | Hemoclav Venous CatheterFIQ · Traditional | Exo, Inc. | 07/07/1983SE |
More from Exo, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926374 | Silicone Catheter Repair KitsKOC · Traditional | 10/07/1994SESK |
| K925819 | AKCESS0CATH KitLFJ · Traditional | 08/02/1994SE |
| K925818 | Akcess-CathLFJ · Traditional | 04/05/1994SE |
| K930630 | Right Atrial CatheterLJS · Traditional | 02/07/1994SN |
| K931120 | Coaxial Acute CatheterLFJ · Traditional | 01/14/1994SE |
| K920634 | Splittable Sheath Introducer SetLFJ · Traditional | 01/14/1994SE |
| K914936 | Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional | 04/23/1992SESK |
| K920331 | Right Atrial Catheter KitsDQY · Traditional | 04/22/1992SESK |
| K914826 | Akcess-Cath KitLFJ · Traditional | 04/10/1992SESK |
| K915215 | Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional | 03/27/1992SESK |
Questions and answers
When was ST Series Saf-T-Shunts Arteriovenous Cannula cleared by the FDA?
ST Series Saf-T-Shunts Arteriovenous Cannula (K892887) received a 510(k) decision of Substantially Equivalent on May 15, 1989, 25 days after the submission was received.
What is the product code of K892887?
The FDA product code is FIQ – Cannula, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.