Medtronic, Inc. · Class II · Cleared Jan 14, 2026
| K-number | K253511 |
| Device name | Concerto Versa Detachable Coil |
| Applicant | Medtronic, Inc. |
| Product code | KRD |
| Device class | Class II |
| Decision date | Jan 14, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.3300 |
The Concerto Versa™ Detachable Coil is an embolization device consisting of a platinum-tungsten coil attached to a delivery pusher and detacher mechanism. It is indicated for arterial and venous embolization in the peripheral vasculature to occlude blood vessels.
The subject device differs from the predicate in two minor dimensions: the Delivery Wire Distal OD increased from 0.010" to 0.0142", the Delivery Pusher Retainer Ring OD increased from 0.0100" to 0.0140", and the Fiber length increased from 3.5mm to 4.5mm. All other specifications including coil sizes, shapes, wire diameters, materials, and sterilization method remain identical.
ISO 10993-1 for biocompatibility; ISO intracutaneous irritation testing; ISO acute systemic toxicity study; ISO materials mediated pyrogenicity testing. Testing also included dimensional inspection, fatigue and detachment testing, tensile testing, migration resistance testing, and hemocompatibility evaluation.
Non-clinical testing demonstrates substantial equivalence because the subject device maintains the same indications for use, classification, regulation, coil specifications, and general design as the predicate device. The minor dimensional changes to the delivery pusher components fell within pre-determined product specifications and all performance and biocompatibility testing met acceptance criteria.
View the full FDA submission: accessdata.fda.gov