Veta Peritoneal Dialysis Catheter
FDA 510(k) K113354 · Pfm Medical, Inc.
510(k) numberK113354
Submission
- Device name
- Veta Peritoneal Dialysis Catheter
- Applicant
- Pfm Medical, Inc.
Carlsbad, CA, US - Received
- November 14, 2011
- Decision date
- March 13, 2012
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K031351 | Flex-Neck PD Catheter, InfantFJS · Traditional | Medigroup, Inc. | 09/17/2003SE |
More from Medigroup, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242763 | JetCan® Pro Safety Huber NeedleFPA · Traditional | 05/02/2025SE |
| K241278 | ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional | 01/14/2025SE |
| K221779 | ASEPT Peritoneal Drainage SystemPNG · Traditional | 05/02/2023SESK |
| K213666 | NuCath Wedge Pressure CatheterDQO · Traditional | 10/06/2022SE |
| K201137 | Asept Surgical Face MaskFXX · Abbreviated | 08/19/2020SE |
| K192802 | primeMidline CathetersPND · Special | 10/28/2019SE |
| K173114 | primeMidline CathetersPND · Traditional | 03/07/2018SE |
| K140137 | Safety Biopsy Needle SystemFCG · Traditional | 03/25/2014SE |
| K122402 | LPP (Low Profile Port)LJT · Traditional | 07/16/2013SE |
| K110914 | Triple Lumen PFM PiccLJS · Traditional | 09/21/2011SE |
Questions and answers
When was Veta Peritoneal Dialysis Catheter cleared by the FDA?
Veta Peritoneal Dialysis Catheter (K113354) received a 510(k) decision of Unknown on March 13, 2012, 120 days after the submission was received.
What is the product code of K113354?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.