Parallel Dual Lumen Subclavian Cannula
FDA 510(k) K834358 · Vas-Cath of Canada , Ltd.
510(k) numberK834358
Submission
- Device name
- Parallel Dual Lumen Subclavian Cannula
- Applicant
- Vas-Cath of Canada , Ltd.
Mchenry, IL, US - Received
- December 13, 1983
- Decision date
- April 2, 1984
- 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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K875188 | Luer Lock Connectors / Ridig P.V.C.LFJ · Traditional | 03/02/1988SE |
| K871817 | Vas-Cath Peritoneal Dialysis CatheterFJS · Traditional | 07/16/1987SE |
| K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K871487 | Vas-Cath Permanent Single Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K863982 | Vas-Cath Pericardiocentesis Catheter, Set & TrayJCY · Traditional | 10/24/1986SE |
| K853283 | Vaccess TM 4006LFJ · Traditional | 08/22/1985SE |
| K844854 | Opti-Flow Digital Subtraction Angiography Cat-KitDQO · Traditional | 05/21/1985SE |
| K844800 | Opti-Flow & Opti-Torque Angiographic CathetersDQO · Traditional | 05/16/1985SE |
| K850009 | Evans, Vas-Cath Epidural Needle & CatheterBSO · Traditional | 05/13/1985SE |
| K844434 | Vaccess 3000 Single Lumen Jugular Cannula-CathLFJ · Traditional | 03/13/1985SE |
Questions and answers
When was Parallel Dual Lumen Subclavian Cannula cleared by the FDA?
Parallel Dual Lumen Subclavian Cannula (K834358) received a 510(k) decision of Substantially Equivalent on April 2, 1984, 111 days after the submission was received.
What is the product code of K834358?
The FDA product code is FIQ – Cannula, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.