Evolution Microcatheter
510(k) K945666
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945666 | Date21 Jun 1995 | 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- Withdrawn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
- Evolution(Tm) Microcatheter
- 510(k) Number
- FDA Product Code
- KRA
- FDA applicant
- Boston Scientific Corp
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1210
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Evolution Microcatheter is a catheter, continuous flush (product code KRA), designed for use in cardiovascular procedures. It is intended for precise delivery of contrast media, fluids, or therapeutic agents within coronary and peripheral vascular systems, facilitating diagnostic imaging and interventional techniques. Its structure supports selective catheterisation and maintains patency through continuous flushing, reducing occlusion risks during procedures.
This device is supplied as a single-use, non-sterile catheter (as per regulatory submission) and is classified under FDA 510(k) clearance K945666 with a substantially equivalent determination. It falls under Class II – Special Controls for cardiovascular applications, adhering to regulation 870.1210. Multiple reference codes (e.g., 3012543881, 1000117748) correspond to its regulatory filings, though specific sizes or MRI safety data are not detailed in the provided records.
Other devices from Boston Scientific
Questions
AI-generated answers, 1 Oct 2026
What is the Evolution Microcatheter designed for?
The Evolution Microcatheter is specifically designed for use in cardiovascular procedures. It facilitates precise delivery of contrast media, fluids, or therapeutic agents within coronary and peripheral vascular systems. This enables accurate diagnostic imaging and effective interventional techniques, while its continuous flush feature helps maintain catheter patency and minimizes occlusion risks during procedures.
Is the Evolution Microcatheter sterile and single-use?
The Evolution Microcatheter is supplied as a single-use device and is classified as non-sterile according to regulatory submission records. This means it is intended for one-time use only and should not be reused or resterilized.
What types of procedures can the Evolution Microcatheter be used in?
This catheter is intended for use in both coronary and peripheral vascular procedures. Its design supports selective catheterization, making it suitable for diagnostic imaging and interventional techniques where precise delivery of contrast media or therapeutic agents is required.
Are there different sizes or models of the Evolution Microcatheter?
The Evolution Microcatheter comes in multiple reference codes, indicating various regulatory filings and potentially different models or configurations. However, the provided records do not specify exact sizes or detailed MRI safety data. For precise sizing or model selection, refer to the manufacturer’s documentation or contact their support team.
How should the Evolution Microcatheter be stored?
Since the Evolution Microcatheter is non-sterile and single-use, it should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Follow the manufacturer’s guidelines for proper packaging and storage conditions to ensure device integrity until use. Avoid exposure to moisture or contaminants.