Single Needle Subclavian Vein MWI250/260
FDA 510(k) K831440 · Med-West, Inc.
510(k) numberK831440
Submission
- Device name
- Single Needle Subclavian Vein MWI250/260
- Applicant
- Med-West, Inc.
Walker, MI, US - Received
- May 5, 1983
- Decision date
- June 3, 1983
- 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 |
|---|---|---|
| K880877 | Contrast Injection DeviceDXT · Traditional | 05/31/1988SE |
| K880398 | Power Toilet ElevatorINO · Traditional | 03/17/1988SE |
| K874470 | Mwi 400 Wound DressingNAD · Traditional | 12/18/1987SN |
| K872724 | Sheath/DilatorsDRE · Traditional | 09/15/1987SE |
| K854612 | Acute Hemodialysis Tray, CAT.#09-9540-7LFK · Traditional | 01/03/1986SESD |
| K852162 | Mni 400 Injection CapsLFJ · Traditional | 06/12/1985SE |
| K842342 | Mwi 888 & 666 Double Lumen Subclavian · Traditional | 06/14/1984SESP |
| K832124 | CPC, Couble Lumen Cardioplegia-Air AspiDWF · Traditional | 08/12/1983SE |
| K831828 | Teflon Femoral Catheter Mwi 100,10 &LFK · Traditional | 07/07/1983SE |
| K831401 | Single Needle Subclavian Vein AccessFIQ · Traditional | 06/03/1983SE |
Questions and answers
When was Single Needle Subclavian Vein MWI250/260 cleared by the FDA?
Single Needle Subclavian Vein MWI250/260 (K831440) received a 510(k) decision of Substantially Equivalent on June 3, 1983, 29 days after the submission was received.
What is the product code of K831440?
The FDA product code is FIQ – Cannula, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.