Vas-Cath Peritoneal Dialysis Catheter
FDA 510(k) K871817 · Vas-Cath of Canada , Ltd.
510(k) numberK871817
Submission
- Device name
- Vas-Cath Peritoneal Dialysis Catheter
- Applicant
- Vas-Cath of Canada , Ltd.
Ontario, L5a 3v3, CA - Received
- May 11, 1987
- Decision date
- July 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJS – Catheter, Peritoneal, Long-Term Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter…FJS · Traditional | Covidien, LLC | 01/14/2022SE |
| K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…FJS · Traditional | Covidien, LLC | 07/27/2018SESK |
| K130441 | Faller StyletFJS · Traditional | Medionics International, Inc. | 04/19/2013SE |
| K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)FJS · Traditional | Medical Components, Inc. | 09/05/2012SESK |
| K120130 | Faller TrocarFJS · Traditional | Medigroup, Inc. | 05/21/2012SE |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | Pfm Medical, Inc. | 03/13/2012SESK |
| K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional | Medigroup, Inc. | 08/31/2007SESK |
| K070730 | Flex-Neck Arc CatheterFJS · Traditional | Medigroup, Inc. | 07/03/2007SESK |
| K060897 | Embedding Tool, Model TE-1000FJS · Traditional | Medigroup, Inc. | 07/18/2006SE |
| K053123 | PD CathFJS · Traditional | Med-Conduit, Inc. | 03/29/2006SE |
More from Med-Conduit, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K875188 | Luer Lock Connectors / Ridig P.V.C.LFJ · Traditional | 03/02/1988SE |
| 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 |
| K844433 | Vaccess 2000 Single Lumen Subclavian CannulaLFJ · Traditional | 03/13/1985SE |
Questions and answers
When was Vas-Cath Peritoneal Dialysis Catheter cleared by the FDA?
Vas-Cath Peritoneal Dialysis Catheter (K871817) received a 510(k) decision of Substantially Equivalent on July 16, 1987, 66 days after the submission was received.
What is the product code of K871817?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.