Concerto Versa Detachable Coil
510(k) K253511
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253511 | Date14 Jan 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Concerto Versa Detachable Coil is a vascular embolization device designed for arterial and venous embolization in the peripheral vasculature. Classified as a Vascular Device for Promoting Embolization, it is intended to occlude blood vessels to control bleeding or treat vascular abnormalities. Constructed as a detachable coil, it allows precise deployment within the vascular system under radiographic guidance. Its design supports both arterial and venous applications, ensuring versatility in interventional radiology procedures.
The Concerto Versa Detachable Coil is supplied as a single-use, sterile product intended for use in interventional radiology settings. It is classified under FDA Device Class II (KRD) and has received FDA 510(k) clearance through a traditional review process. The device is compatible with standard catheter systems and is intended for one-time use. Storage and handling must adhere to standard sterile medical device protocols. The device is regulated under FDA regulation number 870.3300 and is not labeled for MRI compatibility.
Concerto Versa Detachable Coil
Other devices from Medtronic, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Concerto Versa Detachable Coil used for?
The Concerto Versa Detachable Coil is designed for vascular embolization procedures in both arterial and venous systems within the peripheral vasculature. It is intended to occlude blood vessels to control bleeding or treat vascular abnormalities, such as arteriovenous malformations or tumors, under radiographic guidance. Its detachable coil design allows for precise deployment, ensuring targeted treatment in interventional radiology settings.
How is the Concerto Versa Detachable Coil supplied and what are its sterility and usage guidelines?
The Concerto Versa Detachable Coil is supplied as a single-use, sterile product, meaning it is intended for one-time use only in a clinical setting. Sterility is maintained through standard medical device packaging, and it must be handled using aseptic techniques to preserve its sterile condition. Always follow manufacturer-provided instructions for opening, deployment, and disposal to ensure compliance with sterile medical device protocols.
Is the Concerto Versa Detachable Coil compatible with standard catheter systems?
Yes, the Concerto Versa Detachable Coil is explicitly designed to be compatible with standard catheter systems commonly used in interventional radiology. This compatibility ensures seamless integration with existing procedural workflows, allowing clinicians to deploy the coil through familiar catheter platforms while maintaining procedural efficiency and safety.
What storage and handling requirements apply to the Concerto Versa Detachable Coil?
The device must be stored and handled according to standard sterile medical device protocols to maintain its integrity and sterility. This includes storing it in a clean, dry environment, away from direct sunlight or extreme temperatures, and protecting it from physical damage. Always check the packaging for expiration dates and follow the manufacturer’s guidelines for proper storage conditions to ensure optimal performance and safety.
Is the Concerto Versa Detachable Coil labeled for MRI compatibility?
No, the Concerto Versa Detachable Coil is explicitly not labeled for MRI compatibility. This means it should not be used in or near MRI environments, as its materials or deployment may pose risks during magnetic resonance imaging procedures. Always verify the device’s labeling and consult manufacturer guidelines before use in any imaging setting.