Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip
by Kendall
510(k) K043272
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043272 | Date22 Dec 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MSD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Pallindrome 14.5Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip is an intravascular access device used for hemodialysis, apheresis, and infusion. It features a radiopaque polyurethane shaft with a double-D lumen configuration and a symmetrical tip with added side slots to improve flow performance. The device is designed for long-term vascular access and helps minimize recirculation to improve dialysis efficiency.
It is supplied as a sterile, single-use device intended for use in clinical settings such as dialysis centers or hospitals. The catheter is implanted for chronic hemodialysis access and is not MRI safe unless otherwise specified. Storage conditions and handling should follow manufacturer guidelines. The device has received FDA 510(k) clearance under K043272 and is classified as a Class II medical device under regulation number 876.5540.
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Questions
AI-generated answers, 24 Sep 2026
What is the Pallindrome 14.5Fr Chronic Hemodialysis Catheter used for?
This device is an intravascular access catheter used for hemodialysis, apheresis, and infusion therapies. It is designed for long-term vascular access in chronic hemodialysis patients, with a slotted symmetrical tip to improve flow performance and minimize recirculation during treatment.
How is the Pallindrome 14.5Fr Chronic Hemodialysis Catheter supplied and is it reusable?
The catheter is supplied as a sterile, single-use device intended for one-time implantation in clinical settings such as dialysis centers or hospitals. It is not designed for reuse due to sterility and safety considerations following implantation.
What are the key design features of the Pallindrome 14.5Fr Chronic Hemodialysis Catheter?
It features a radiopaque polyurethane shaft with a double-D lumen configuration and a symmetrical tip with added side slots. These design elements are intended to improve flow performance and reduce recirculation, thereby enhancing dialysis efficiency during chronic use.