Hemofiltration Catheter HF-100
510(k) K890717
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890717 | Date5 Apr 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modification Hemofiltration Catheter Hf-100
- 510(k) Number
- FDA Product Code
- LFK
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Hemofiltration Catheter Hf-100 is a catheter used for hemofiltration. It is classified as a Femoral Catheter and is used in the medical specialties of Gastroenterology and Urology.
The Hemofiltration Catheter Hf-100 is supplied with the product code LFK and is regulated under the regulation number 876.5540. It has been assigned the device class 2 and has the fei numbers 2527072, 3003915875, 3005987240, 2518902, 3000206435, and 1000306216. The device has been cleared with the k number K890717.
Other devices from Vas-Cath, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Hemofiltration Catheter HF-100 used for?
The Hemofiltration Catheter HF-100 is used for hemofiltration in medical specialties such as Gastroenterology and Urology.
How is the Hemofiltration Catheter HF-100 supplied?
The Hemofiltration Catheter HF-100 is supplied with the product code LFK.
What is the regulatory classification of the Hemofiltration Catheter HF-100?
The Hemofiltration Catheter HF-100 is classified as a Class 2 device and is regulated under the regulation number 876.5540.