Catheter, Radiopaque Tenckhoff
FDA 510(k) K782057 · Dravon Medical, Inc.
510(k) numberK782057
Submission
- Device name
- Catheter, Radiopaque Tenckhoff
- Applicant
- Dravon Medical, Inc.
Mchenry, IL, US - Received
- December 7, 1978
- Decision date
- February 27, 1979
- 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 |
|---|---|---|
| K873455 | S3086 Arterial, S3087 Venous Neonatal HemodialysisFJK · Traditional | 09/14/1987SE |
| K860770 | AM-100 I/A AmpacHQC · Traditional | 04/21/1986SE |
| K832739 | Stediflo Infusion SetLDR · Traditional | 12/22/1983SE |
| K831842 | Dravon T ClampKDC · Traditional | 09/26/1983SE |
| K812772 | Peritoneal Dialysis Cycler Set (8UNIT)KDJ · Traditional | 10/19/1981SE |
| K812771 | Peritoneal Dialysis DrainageKDJ · Traditional | 10/19/1981SE |
| K811851 | S-610 Shunt Adaptor SetKNR · Traditional | 08/31/1981SE |
| K800435 | Hemostatic/Tube Occluding ForcepsGEN · Traditional | 03/12/1980SE |
| K782058 | Catheter, Beta-Cap-PeritonealFJS · Traditional | 02/27/1979SE |
| K781755 | Dap-PakKDJ · Traditional | 02/15/1979SE |
Questions and answers
When was Catheter, Radiopaque Tenckhoff cleared by the FDA?
Catheter, Radiopaque Tenckhoff (K782057) received a 510(k) decision of Substantially Equivalent on February 27, 1979, 82 days after the submission was received.
What is the product code of K782057?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.