Swan-Neck Peritoneal Dialysis Catheters
FDA 510(k) K862046 · Accurate Surgical Instruments Co.
510(k) numberK862046
Submission
- Device name
- Swan-Neck Peritoneal Dialysis Catheters
- Applicant
- Accurate Surgical Instruments Co.
Toronto Canado M5v 1y9, CA - Received
- May 29, 1986
- Decision date
- June 19, 1986
- 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 |
|---|---|---|
| K950042 | Swan Neck Presternal Peritoneal Dialysis CatheterFJS · Traditional | 12/15/1995SE |
| K920515 | InsertionFJS · Traditional | 05/04/1992SE |
| K910786 | Trocar (Faller Stylet)FJS · Traditional | 09/19/1991SE |
| K910785 | Titanium Catheter ExtenderFJS · Traditional | 08/22/1991SE |
| K910787 | Titanium Connector (2 Part)FKO · Traditional | 08/15/1991SE |
| K850214 | Sterile Catheters-Catheter Peritoneal Long-Term inFJS · Traditional | 07/26/1985SE |
| K813488 | Catheter RegularFJS · Traditional | 12/31/1981SE |
| K813487 | Catheter Bubble StandFKX · Traditional | 12/31/1981SE |
Questions and answers
When was Swan-Neck Peritoneal Dialysis Catheters cleared by the FDA?
Swan-Neck Peritoneal Dialysis Catheters (K862046) received a 510(k) decision of Substantially Equivalent on June 19, 1986, 21 days after the submission was received.
What is the product code of K862046?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.