15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
FDA 510(k) K063431 · Spire Biomedical, Inc.
510(k) numberK063431
Submission
- Device name
- 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
- Applicant
- Spire Biomedical, Inc.
Bedford, MA, US - Received
- November 13, 2006
- Decision date
- January 29, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code MSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241581 | Hemodialysis CatheterMSD · Traditional | Haolang Medical USA Corporation | 05/16/2025SESK |
| K210461 | End CapMSD · Traditional | Medical Components Inc (Medcomp) | 09/14/2021SE |
| K203575 | GlidePath Retro Long-Term Hemodialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 07/01/2021SESK |
| K211410 | GlidePath 13F Long-Term Hemodialysis CatheterMSD · Special | Bard Peripheral Vascular, Inc. | 06/04/2021SESK |
| K203767 | Pristine Long-Term Hemodialysis CatheterMSD · Traditional | C B Bard, Inc. | 04/02/2021SESK |
| K202150 | GlidePath 7.5F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 11/18/2020SESK |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD · Special | Medical Components, Inc. (dba MedComp) | 09/03/2020SE |
| K200627 | GlidePath 10F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 06/22/2020SESK |
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…MSD · Traditional | C. R. Bard | 03/05/2020SESK |
| K182443 | Pristine Hemodialysis CatheterMSD · Traditional | Pristine Access Technologies , Ltd. | 05/31/2019SE |
More from Pristine Access Technologies , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24…MSD · Traditional | 01/29/2008SE |
| K073093 | Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24…MSD · Traditional | 01/22/2008SE |
| K063441 | 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…MSD · Traditional | 02/12/2007SE |
| K062435 | Repair Kit for Xpresso, Decathlon, and Alta LR CathetersNFK · Traditional | 12/05/2006SE |
| K060288 | Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersMSD · Traditional | 09/01/2006SESK |
| K060155 | 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsMSD · Traditional | 05/09/2006SE |
| K042858 | 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated TipsMSD · Traditional | 12/03/2004SE |
| K041559 | 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…MSD · Traditional | 07/30/2004SESK |
| K040509 | Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32…MSD · Special | 04/19/2004SE |
| K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH…MSD · Traditional | 12/23/2003SESK |
Questions and answers
When was 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 cleared by the FDA?
15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (K063431) received a 510(k) decision of Substantially Equivalent on January 29, 2007, 77 days after the submission was received.
What is the product code of K063431?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.