Peritoneal Dialysis Catheters and Adapters
FDA 510(k) K993149 · Medionics International, Inc.
510(k) numberK993149
Submission
- Device name
- Peritoneal Dialysis Catheters and Adapters
- Applicant
- Medionics International, Inc.
Markham, Ontario, CA - Received
- September 21, 1999
- Decision date
- April 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K130441 | Faller StyletFJS · Traditional | 04/19/2013SE |
| K994218 | Easy Care and Tubing SetsFKX · Special | 02/10/2000SE |
| K945567 | QC CapKDJ · Traditional | 02/07/1995SE |
| K910173 | Selectra and Tubing SetsFKX · Traditional | 01/13/1992SE |
| K883393 | Capd Disposable Y System - Dy SetKDJ · Traditional | 11/03/1988SE |
| K842305 | C.A.P.D. Automatic Heater PDH 200FKX · Traditional | 06/25/1984SE |
| K832141 | Microstar VC1 Volumetric CyclerFKX · Traditional | 10/14/1983SE |
| K831766 | Microstar VciFKX · Traditional | 10/14/1983SE |
| K821328 | C.A.P.D. Automatic Heater #Pdc 2000 HCPKPF · Traditional | 07/28/1982SE |
Questions and answers
When was Peritoneal Dialysis Catheters and Adapters cleared by the FDA?
Peritoneal Dialysis Catheters and Adapters (K993149) received a 510(k) decision of Substantially Equivalent on April 28, 2000, 220 days after the submission was received.
What is the product code of K993149?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.