InfusionCath
by Id, LLC
510(k) K041517
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041517 | Date5 Aug 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QEY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5150
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The InfusionCath is a Mechanical Thrombolysis Catheter, designed to temporarily occlude a vessel while delivering physician-specified fluids, such as thrombolytics. It features a distal occlusion balloon, a catheter body with elution holes, and a proximal trifurcated Luer connection hub. This device is intended for use in peripheral vascular applications to facilitate localized treatment delivery.
The InfusionCath is supplied as a single-use device and is regulated under FDA 510(k) clearance (K041517) with a classification of Class II (QEY). It is intended for use in cardiovascular procedures and must be handled in accordance with sterile medical device protocols. No MRI safety information is specified, and storage conditions align with standard sterile catheter requirements. Authorizations are limited to the stated FDA 510(k) clearance.
Questions
AI-generated answers, 1 Oct 2026
What is the InfusionCath designed for in medical procedures?
The InfusionCath is a mechanical thrombolysis catheter specifically designed to temporarily occlude a blood vessel while allowing physician-specified fluids, such as thrombolytics, to be delivered locally. This facilitates targeted treatment in peripheral vascular applications, helping to break down clots in controlled areas of the circulatory system.
How is the InfusionCath supplied and intended for use?
The InfusionCath is supplied as a single-use device, meaning it is intended for one-time use only and must not be reused. This ensures sterility and safety for each procedure. It is regulated under FDA 510(k) clearance (K041517) and must be handled according to sterile medical device protocols to maintain its integrity and effectiveness.
Does the InfusionCath have any special features that distinguish it?
Yes, the InfusionCath features a distal occlusion balloon to block blood flow in the targeted vessel, a catheter body with elution holes for precise fluid delivery, and a proximal trifurcated Luer connection hub for secure attachment to infusion systems. These design elements enable localized thrombolytic treatment while maintaining vessel occlusion.
What storage conditions should be followed for the InfusionCath?
The InfusionCath should be stored under standard sterile catheter conditions, as with other sterile medical devices. This typically includes keeping it in its original packaging, away from direct sunlight, extreme temperatures, and contamination sources. Always follow manufacturer guidelines to ensure sterility and functionality before use.
Is there any specific safety information regarding MRI compatibility for the InfusionCath?
The provided data does not specify any MRI safety information for the InfusionCath. If MRI imaging is required after or during use, clinicians should consult the device’s labeling or manufacturer for guidance to avoid potential risks associated with magnetic fields.