Hemofiltration Catheter HF-100

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K840322 ↗

FDA Product Code

FIQ

FDA applicant

Vas-Cath of Canada , Ltd.

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Vas-Cath of Canada, Ltd. →

• What clinical applications is the HF-100 designed for?

  The HF-100 is intended to provide vascular access for arteriovenous shunt applications during hemofiltration procedures. It is specifically listed for use in gastroenterology and urology settings, where extracorporeal blood purification is required.

• How is the HF-100 supplied and what is known about its sterility?

  The source data does not specify packaging details or sterility status. Because sterility information is absent, purchasers should request the manufacturer’s labeling or packaging insert to confirm whether the catheter is supplied sterile and under what conditions.

• Is the HF-100 a single‑use or reusable device?

  The provided information does not indicate whether the catheter is intended for single‑use or multiple uses. In the absence of explicit guidance, clinicians should follow standard institutional policies and seek clarification from Vas‑Cath of Canada regarding reuse recommendations.

• Are there multiple sizes or models of the HF-100 available?

  The device description only references the HF-100 model without mentioning alternative sizes or variants. Therefore, no additional size or model options can be confirmed from the available data.

• What regulatory clearance does the HF-100 have?

  The HF-100 received traditional 510(k) clearance (K840322) from the U.S. FDA, classified as a Class II device under product code FIQ and regulation 876.5540. This indicates it was found substantially equivalent to a predicate device.