Concerto Versa™ Detachable Coil
Device Facts
| Record ID | K261866 |
|---|---|
| Device Name | Concerto Versa™ Detachable Coil |
| Applicant | Medtronic, Inc. |
| Product Code | KRD · Cardiovascular |
| Decision Date | Jun 24, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
Device Story
Concerto Versa™ Detachable Coil is a vascular embolization implant; consists of platinum-tungsten coil attached to composite delivery pusher; used with hand-held Instant Detacher (I.D.) accessory for coil release. Device is single-use, sterile, and MR Conditional. Operated by physicians in clinical settings for peripheral vasculature embolization. Input is manual manipulation by clinician; output is mechanical occlusion of target vessel. Benefits include controlled embolization for peripheral vascular conditions.
Clinical Evidence
Bench testing only. Design verification and validation testing, including track force in sheath, were performed. All results met pre-determined acceptance criteria.
Technological Characteristics
Platinum-tungsten embolization coil; composite delivery pusher; hand-held Instant Detacher accessory. Sterilization via Ethylene Oxide (EO). Biocompatibility per ISO 10993-1. MR Conditional. Dimensions: 15-65cm length; 0.00275" wire OD; 0.0224" primary wind OD.
Indications for Use
Indicated for arterial and venous embolization in the peripheral vasculature.
Regulatory Classification
Identification
A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
Predicate Devices
- Concerto Versa™ Detachable Coil (K253511)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
06/24/2026
Medtronic, Inc.
Rishu Rathee
Sr Regulatory Affairs Specialist
2300 Berkshire Ln. N.
Plymouth, Minnesota 55441
Re: K261866
Trade/Device Name: Concerto Versa™ Detachable Coil
Regulation Number: 21 CFR 870.3300
Regulation Name: Vascular embolization device
Regulatory Class: Class II
Product Code: KRD
Dated: June 4, 2026
Received: June 4, 2026
Dear Rishu Rathee:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, FINN E. DONALDSON - S
Digitally signed by FINN E. DONALDSON - S
Date: 2026.06.24
14:43:21 -04'00'
Finn Donaldson
Acting Assistant Director
DHT2C: Division of Coronary and
Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K261866
Device Name
Concerto Versa™ Detachable Coil
Indications for Use (Describe)
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
## Submitter Information
| Applicant/ Submitter Name and Address | Medtronic 2300 Berkshire Lane N Plymouth, MN 55441 USA |
| --- | --- |
| Contact Person | Rishu Rathee Senior Regulatory Affairs Specialist Email: rishu.rathee@medtronic.com |
| Date Prepared | 4 June 2026 |
| Device Trade Name | Concerto Versa™ Detachable Coil |
## Subject Device
| Device Classification | Regulatory Class: II |
| --- | --- |
| Classification Panel | Cardiovascular |
| Classification Name | Vascular Embolization Device |
| Regulation Number | 21 CFR 870.3300 |
| Product Code | KRD |
## Predicate Device
| Device Trade name | Concerto Versa™ Detachable Coil |
| --- | --- |
| 510(K) Number / Clearance Date | K253511 / January 14, 2026 |
## Device Description
The Concerto Versa™ Detachable Coil is an embolization coil indicated for arterial and venous embolization in the peripheral vasculature. It consists of a platinum-tungsten embolization implant coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately. The Concerto Versa™ Detachable Coil is for single use and provided sterile.
## Indications for Use
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
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## Predicate Comparison
A comparison of the Concerto Versa™ Detachable Coil to the predicate device indicates the following similarities:
| Attribute | Predicate Device | Subject Device |
| --- | --- | --- |
| Trade Name | Concerto Versa™ Detachable Coil | Concerto Versa™ Detachable Coil |
| Classification | Class II, KRD | Same |
| Regulation Number | 870.3300 – Vascular Embolization Device | Same |
| Indications For Use | The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature. | Same |
| Sizes Available | 3-32mm Loop OD 5-65cm Length | No Loop OD 15-65cm Length |
| Coil Shape | Spherical and Multi-Spherical | Shapeless |
| Coil Wire Outer Diameter (OD) | 3-6mm: 0.0025" 7-9mm: 0.00275" 10-32mm: 0.0035" | No OD: 0.00275" |
| Attribute | Predicate Device | Subject Device |
| Primary Wind OD | 3-6mm: 0.0222" 7-9mm: 0.0224" 10-32mm: 0.0225" | No OD: 0.0224" |
| Fiber OD/Length | 0.0015"/4.5mm | Same |
| **Delivery Pusher** | | |
| Delivery Wire Length (Pusher Length) | 188cm | Same |
| Delivery Wire Distal OD (With Outer Jacket) | 0.0142" | Same |
| Delivery Wire Proximal OD (Unibody) | 0.0200" | Same |
| Pusher Taper Length | 158mm | Same |
| Deliver Pusher Retainer Ring OD | 0.0140" | Same |
| Marker Coil OD/Wire Size | 0.0096"/0.00175" | Same |
| **General** | | |
| Biocompatibility | Per ISO 10993-1 | Same |
| MRI Compatibility | MR Conditional | Same |
| Sterilization | Ethylene Oxide (EO) | Same |
The following modifications were made to the predicate device, Concerto Versa™ Detachable Coil (K253511):
- Expanding predicate device size range by adding four new models with
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Customer-Facing Numbers (CFNs): (CVP-15, CVP-30, CVP-40, CVP-65) offered in four coil length options (15 cm, 30 cm, 40 cm, and 65 cm) labeled by only length.
- Labeling updates include details of new device size range models.
## Summary of Non-Clinical Data
Medtronic performed design verification and validation testing to provide evidence to demonstrate substantial equivalence of the subject device to the predicate device. All data met the acceptance criteria and fell within pre-determined product specifications. The following testing was performed:
Performance Testing:
- Track Force in Sheath
## Conclusion
Non-clinical testing supports substantial equivalence of the subject device, Concerto Versa™ Detachable Coil, to the predicate device, Concerto Versa™ Detachable Coil (K253511).
