CG Future Annuloplasty System, Model 638R
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061127 FDA 510(k)
- FDA Product Code
- KRH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3800 FDA 510(k)
- Regulation Number
- 870.3800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CG Future Annuloplasty System, Model 638R, is an annuloplasty ring designed for mitral valve reconstruction or remodeling. It is classified as a Ring, Annuloplasty under FDA regulation 870.3800 and falls under Class II medical devices. This device is intended for targeted remodeling of pathological mitral valves, aiding in the restoration of valve function through structural support.
The system is supplied as a single-use device and is regulated under FDA 510(k) clearance (K061127) with a decision of Substantially Equivalent (SESE). It is intended for use in cardiovascular procedures and is manufactured by Medtronic Vascular. The device is packaged individually, adhering to sterile standards for surgical use. No MRI safety information is specified in the available data.
Frequently asked questions
What is the CG Future Annuloplasty System, Model 638R used for?
The CG Future Annuloplasty System, Model 638R is specifically designed for mitral valve reconstruction or remodeling. It provides structural support to pathological mitral valves, helping to restore proper valve function by reshaping the mitral annulus during surgical procedures.
Is the CG Future Annuloplasty System, Model 638R intended for reuse or single-use?
This device is supplied as a single-use item. It is individually packaged and adheres to sterile standards for surgical use, ensuring safety and reliability for one-time procedural application.
What regulatory pathway does the CG Future Annuloplasty System, Model 638R follow?
The CG Future Annuloplasty System, Model 638R is classified under FDA regulation 870.3800 as a Class II medical device and has received FDA 510(k) clearance (K061127) with a decision of Substantially Equivalent (SESE). This clearance was granted by the Cardiovascular (CV) Advisory Committee.
How is the CG Future Annuloplasty System, Model 638R packaged and stored?
The device is packaged individually in sterile packaging, suitable for surgical use. Proper storage should follow manufacturer guidelines to maintain sterility and integrity until use.
Does the CG Future Annuloplasty System, Model 638R have any specific safety information regarding MRI?
The available data for the CG Future Annuloplasty System, Model 638R does not specify any MRI safety information. Clinicians should consult the manufacturer’s instructions for use for any relevant MRI precautions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CG Future™ Annuloplasty Ring & Band | Medtronic, CG Future™ Annuloplasty Ring & Band | Medtronic (Europe), CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R 510(k)… - FDA.report, CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R (K061127) — FDA 510(k ..., PDF 200200908c EN - palmmed.com.jo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061127 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K061127 24 fields · synced Oct 1, 2026