Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
FDA 510(k) K213602 · Covidien, LLC
510(k) numberK213602
Submission
- Device name
- Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
- Applicant
- Covidien, LLC
Mansfield, MA, US - Received
- November 15, 2021
- Decision date
- January 14, 2022
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|---|
| 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 |
| K031351 | Flex-Neck PD Catheter, InfantFJS · Traditional | Medigroup, Inc. | 09/17/2003SE |
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Questions and answers
When was Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit cleared by the FDA?
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit (K213602) received a 510(k) decision of Substantially Equivalent on January 14, 2022, 60 days after the submission was received.
What is the product code of K213602?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.