018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
by Creagh Medical Ltd. Dba Surmodics, Inc.
510(k) K242419
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242419 | Date15 Nov 2024 | 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- Withdrawn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
- LIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Catheter, Angioplasty, Peripheral, Transluminal (OTW PTA balloon dilatation catheter) designed for percutaneous transluminal angioplasty. It features a semi-compliant hydrophilic-coated balloon at the distal tip, two radiopaque markers for precise placement, and a bifurcated manifold for attachment to a 0.018" guidewire and inflation device. The catheter is intended to dilate stenotic vessels or arteriovenous dialysis fistulae in peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal arteries, and synthetic grafts.
The catheter is supplied sterile and intended for single-use in clinical settings under fluoroscopic guidance. It is positioned over a guidewire, inflated with contrast medium to expand stenotic lesions, and then deflated for removal. The device is classified as Class II under FDA regulation 870.1250 and holds a 510(k) clearance (K242419) for use in peripheral vascular interventions. No MRI safety information is specified, and sizes are determined by the listed model references.
Questions
AI-generated answers, 1 Oct 2026
What is the 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter used for?
This catheter is designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic lesions in peripheral vasculature. It is specifically intended for use in arteries such as the iliac, femoral, popliteal, infra-popliteal, renal arteries, and synthetic grafts. Additionally, it can be used to treat arteriovenous dialysis fistulae by expanding narrowed vessels to restore blood flow.
How is the catheter supplied and prepared for use?
The catheter is supplied sterile and intended for single-use in clinical settings. It is positioned over a 0.018" guidewire and requires fluoroscopic guidance for precise placement. The device is inflated with contrast medium to expand stenotic lesions, then deflated and removed after use.
Is the catheter reusable or single-use?
The catheter is explicitly designed for single-use only. It is supplied sterile and intended to be discarded after a single procedure to ensure patient safety and maintain sterility standards.
What sizes or models are available for this catheter?
The catheter comes in multiple sizes, each identified by specific model references listed in the regulatory documentation. These references correspond to different balloon diameters and lengths, allowing clinicians to select the appropriate size for their patient’s specific anatomical requirements.
How should the catheter be stored before use?
The catheter should be stored in its original, sealed packaging to maintain sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for storage to ensure optimal performance and sterility.