15.5F Jet Medical Free Flow Long-Term Coaxial Catheter
FDA 510(k) K040328 · Medcomp
510(k) numberK040328
Submission
- Device name
- 15.5F Jet Medical Free Flow Long-Term Coaxial Catheter
- Applicant
- Medcomp
Harleysville, PA, US - Received
- February 10, 2004
- Decision date
- November 24, 2004
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K130889 | Split Cath RGMSD · Traditional | 04/28/2014SESK |
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| K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccLJS · Traditional | 12/21/2010SE |
| K091954 | Micro-Stick SetDYB · Traditional | 01/08/2010SE |
| K092347 | Pro-Picc CTLJS · Special | 09/16/2009SE |
| K091953 | Pro-PiccLJS · Traditional | 09/16/2009SE |
| K090394 | Valved Tearway IntroducerDYB · Traditional | 09/01/2009SE |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenLJS · Traditional | 07/23/2009SE |
| K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model VPI.9S20, VPI.9S50LJS · Special | 06/17/2009SE |
| K081775 | The Medcomp .010 Vascular GuidewiresDQX · Traditional | 03/25/2009SE |
Questions and answers
When was 15.5F Jet Medical Free Flow Long-Term Coaxial Catheter cleared by the FDA?
15.5F Jet Medical Free Flow Long-Term Coaxial Catheter (K040328) received a 510(k) decision of Substantially Equivalent on November 24, 2004, 288 days after the submission was received.
What is the product code of K040328?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.