FDA.reportPublic FDA data

Concerto Versa™

Primary DI
00199150044191
Brand
Concerto Versa™
Company
MEDTRONIC, INC.
Model
CVP-40
Device description
COIL CONCERTO VERSA PACKING CVP-40 US
Published
2026-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261866000Concerto Versa™ Detachable CoilMedtronic, Inc.2026-06-24KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150044191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150044191001991500441911991500441910199150044191

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150044177Concerto Versa™CVP-152026-10-18
00199150044184Concerto Versa™CVP-302026-10-18
00199150044207Concerto Versa™CVP-652026-10-18
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923709Power CordMCS1621PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150044177Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044184Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044207Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724255Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724262Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724279Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724286Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077046DELTAFILLCerenovus, Inc.KRD2016-11-16