Echomark Ultrasonically Located Balloon Catheter
510(k) K903582
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903582 | Date6 Nov 1990 | 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- Withdrawn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
- Full name
- Echomark PTA Ultrasonically Located Balloon Cath.
- 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, 20 Sep 2026
The Echomark Ultrasonically Located Balloon Catheter is a Catheter, Angioplasty, Peripheral, Transluminal designed for percutaneous vascular interventions. It incorporates ultrasound technology to locate and position the balloon within peripheral arteries, facilitating precise angioplasty procedures to restore blood flow in narrowed or obstructed vessels. The device combines mechanical dilation with real-time imaging guidance to enhance procedural accuracy and safety during peripheral arterial treatments.
This catheter is supplied as a single-use, sterile medical device intended for use in controlled clinical settings such as catheterization laboratories. It is classified under 21 CFR 870.1250 and has received FDA 510(k) clearance (K903582) as substantially equivalent to a predicate device. The device is non-magnetic and compatible with standard imaging modalities, though MRI safety is not specified. Available in various sizes and configurations, it must be stored in a clean, dry environment to maintain sterility and functionality prior to use.
Other devices from Catheter Sciences Co.
Questions
AI-generated answers, 20 Sep 2026
What types of peripheral arterial procedures is the Echomark Ultrasonically Located Balloon Catheter designed to assist with?
The Echomark Ultrasonically Located Balloon Catheter is specifically designed to assist in percutaneous vascular interventions for peripheral arterial treatments. It uses ultrasound technology to help locate and position the balloon within narrowed or obstructed vessels, enabling precise angioplasty to restore blood flow in peripheral arteries. This makes it particularly useful for treating stenosis or blockages in arteries outside the heart, such as those in the legs or arms.
Is the Echomark Ultrasonically Located Balloon Catheter reusable, or is it intended for single-use only?
The Echomark Ultrasonically Located Balloon Catheter is explicitly supplied as a single-use device. This design ensures sterility and safety for each procedure, as it is intended for use in controlled clinical settings like catheterization laboratories. Reusing it would compromise sterility and potentially introduce risks to patients.
What storage conditions are required to maintain the device’s sterility and functionality before use?
The device must be stored in a clean, dry environment to preserve its sterility and functionality. Since it is a single-use, sterile catheter, exposure to moisture, dust, or contamination could compromise its integrity before use. Always follow manufacturer guidelines for storage to ensure optimal performance during procedures.
Are there multiple sizes or configurations available for the Echomark Ultrasonically Located Balloon Catheter?
Yes, the Echomark Ultrasonically Located Balloon Catheter is available in various sizes and configurations, as indicated by the multiple registration numbers (e.g., 3011471056, 3011142981, etc.). These variations likely correspond to different balloon diameters, lengths, or shaft profiles to accommodate different peripheral arterial diameters and procedural needs. Always verify the specific size required for the patient’s anatomy before use.
Can this catheter be used with standard imaging modalities, and are there any safety concerns regarding magnetic fields?
The Echomark Ultrasonically Located Balloon Catheter is compatible with standard imaging modalities, including fluoroscopy, which is commonly used during angioplasty procedures. However, its non-magnetic designation does not specify MRI safety—meaning it should not be used in MRI environments unless explicitly confirmed safe by the manufacturer. Always check compatibility with the imaging system in use to avoid risks.