Ebony PTA 0.035 Peripheral Dilatation Catheter
510(k) K143036
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143036 | Date30 Mar 2015 | 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- Withdrawn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
- FDA applicant
- Natec Medical , Ltd.
- 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
The Ebony PTA 0.035 Peripheral Dilatation Catheter is a catheter, angioplasty, peripheral, transluminal designed for percutaneous transluminal angioplasty (PTA). It features an over-the-wire (OTW) configuration with a semi-compliant inflatable balloon and an atraumatic tapered tip, enabling precise dilation of peripheral arteries. The device is intended for use in vascular interventions where controlled expansion of narrowed or occluded vessels is required.
This catheter is supplied sterile and is intended for single-use. It is classified as a Class II device under FDA regulations (870.1250) and holds a FDA 510(k) clearance (K143036). The device is available in a shaft length of 80 cm with a balloon size of 5.00 x 80 mm. Compliance with MRI safety standards and reusable status are not specified in the available data. Storage and handling should follow standard sterile medical device protocols.
Other devices from Natec Medical Ltd
Questions
AI-generated answers, 1 Oct 2026
What is the Ebony PTA 0.035 Peripheral Dilatation Catheter used for?
This catheter is designed specifically for percutaneous transluminal angioplasty (PTA), a procedure used to widen narrowed or blocked peripheral arteries. Its over-the-wire (OTW) configuration and semi-compliant balloon allow for controlled dilation of vessels, making it ideal for vascular interventions where precise expansion is required.
How is the Ebony PTA 0.035 Peripheral Dilatation Catheter supplied and intended for use?
The catheter is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination between procedures. The sterile packaging and single-use designation align with standard medical device protocols for minimizing infection risks.
What are the key specifications of the Ebony PTA 0.035 Peripheral Dilatation Catheter?
The catheter features a shaft length of 80 cm and a balloon size of 5.00 x 80 mm. It is designed with an atraumatic tapered tip to reduce trauma during insertion, and its semi-compliant balloon provides controlled dilation. The 0.035” outer diameter is compatible with standard guidewire systems used in peripheral vascular procedures.
How should the Ebony PTA 0.035 Peripheral Dilatation Catheter be stored?
Since the catheter is sterile and single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight and extreme temperatures. Follow standard sterile medical device storage guidelines to maintain integrity until use. Avoid exposure to moisture or contamination.
Is MRI safety compliance mentioned for the Ebony PTA 0.035 Peripheral Dilatation Catheter?
The provided data does not specify whether the Ebony PTA 0.035 Peripheral Dilatation Catheter complies with MRI safety standards. If MRI compatibility is required for a procedure, additional verification from the manufacturer or product documentation should be consulted to ensure safe use in an MRI environment.