Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, de 31/36SH, DE19/24NH
FDA 510(k) K032061 · Spire Biomedical, Inc.
510(k) numberK032061
Submission
- Device name
- Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, de 31/36SH, DE19/24NH
- Applicant
- Spire Biomedical, Inc.
Bedford, MA, US - Received
- July 3, 2003
- Decision date
- December 23, 2003
- Decision
- Unknown (SESK)
- 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 |
| K063431 | 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28…MSD · Traditional | 01/29/2007SE |
| 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 |
Questions and answers
When was Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, de 31/36SH, DE19/24NH cleared by the FDA?
Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, de 31/36SH, DE19/24NH (K032061) received a 510(k) decision of Unknown on December 23, 2003, 173 days after the submission was received.
What is the product code of K032061?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.