Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip
FDA 510(k) K043272 · Kendall
510(k) numberK043272
Submission
- Device name
- Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip
- Applicant
- Kendall
Mansfield, MA, US - Received
- November 26, 2004
- Decision date
- December 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K092797 | Acute and Chronic Catheter Repair KitNFK · Traditional | 11/19/2009SESK |
| K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…MSD · Special | 11/03/2006SESK |
| K061936 | Kendall Argyle Neonatal/Pediatric Picc, Model 43311LJS · Special | 08/09/2006SE |
| K060972 | Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)MSD · Traditional | 08/04/2006SE |
| K053410 | Gientriport with Universal Single Lumen AdaptorFEG · Traditional | 01/06/2006SE |
| K051584 | 14.5 FR Chronic Hemodialysis Catheter with Insertion Stylets AccessoryMSD · Special | 10/06/2005SE |
| K042461 | Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304LJS · Abbreviated | 12/10/2004SE |
| K042572 | Kendall CO2NFIRM Now CO2 DetectorKNT · Traditional | 11/05/2004SE |
| K041914 | Pallindrome 14.5FR Chronic Hemodialysis CatheterMSD · Traditional | 09/27/2004SE |
| K041006 | Tandem-Cath Hemodialysis Catheter, Model 10 FRMSD · Special | 05/19/2004SE |
Questions and answers
When was Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip cleared by the FDA?
Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (K043272) received a 510(k) decision of Substantially Equivalent on December 22, 2004, 26 days after the submission was received.
What is the product code of K043272?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.