Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II
FDA 510(k) K961392 · Sil-Med Corp.
510(k) numberK961392
Submission
- Device name
- Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II
- Applicant
- Sil-Med Corp.
Taunton, MA, US - Received
- April 11, 1996
- Decision date
- July 18, 1997
- 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 |
|---|---|---|---|
| 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 |
|---|---|---|
| K972521 | Navigator (Stylet) 2006GAH · Traditional | 10/01/1997SE |
| K961194 | Antimicrobial Mediastinal Silicone DrainGBW · Traditional | 08/08/1996SE |
| K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional | 06/26/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | 03/11/1996SE |
| K955463 | Grip-A-BootsLXZ · Traditional | 01/23/1996SE |
| K942709 | Mediastinal Silicone DrainsGBW · Traditional | 01/04/1996SN |
| K926496 | Sil-Slip (Coated/Regular(Non-Coated)Thoracic DrainGBX · Traditional | 05/24/1995SE |
| K926495 | Sil-Slip Round Wound Drain (Coated)/Blue StripeGBX · Traditional | 02/02/1994SE |
| K926408 | Sil-Slip Flat Suction DrainGBX · Traditional | 02/02/1994SE |
| K921424 | Sil-Med Flat Suction DrainGBX · Traditional | 09/28/1992SE |
Questions and answers
When was Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II cleared by the FDA?
Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II (K961392) received a 510(k) decision of Substantially Equivalent on July 18, 1997, 463 days after the submission was received.
What is the product code of K961392?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.