FDA.reportPublic FDA data

CONCERTO VERSA™

Primary DI
00763000322106
Brand
CONCERTO VERSA™
Company
Micro Therapeutics, Inc.
Model
CV-32-65
Device description
Coil CV-32-65 Concerto Versa V02
Published
2021-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
K202850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202850000Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-02-09KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000322106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000322106007630003221067630003221060763000322106

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place and away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536041950PhenomTM Plus CatheterFG19135-1030-1S2019-04-22
00847536005648HyperGlideTM104-45202016-04-03
00199150045532OnyxTM Liquid Embolic System (LES)105-7100-0602026-06-07
00763000488017Axium™ Detachable Coil SystemQC-2.5-4-HELIX2022-10-28
00763000488192Axium™ Detachable Coil SystemQC-10-20-HELIX2022-10-28
00763000488239Axium™ Detachable Coil SystemQC-14-30-HELIX2022-10-28
00763000488260Axium™ Detachable Coil SystemQC-16-40-HELIX2022-10-28
00763000488727Axium™ Detachable Coil SystemQC-25-50-3D2022-10-28
00763000488796Axium™ Detachable Coil SystemNC-3-4-HELIX2022-10-28
00763000488826Axium™ Detachable Coil SystemNC-4-8-HELIX2022-10-28
00763000488864Axium™ Detachable Coil SystemPC-2-3-HELIX2022-10-28
00763000488932Axium™ Detachable Coil SystemPC-4-8-HELIX2022-10-28
00763000488994Axium™ Detachable Coil SystemPC-7-20-HELIX2022-10-28
00763000489052Axium™ Detachable Coil SystemPC-10-20-HELIX2022-10-28
00763000489076Axium™ Detachable Coil SystemPC-2-2-3D2022-10-28
00763000489137Axium™ Detachable Coil SystemPC-4-6-3D2022-10-28
00847536032866AxiumTMNC-2-6-HELIX2019-06-29
00847536033306AxiumTMPC-6-15-3D2019-06-29
00847536033368AxiumTMPC-8-20-3D2019-06-29
00847536029668AxiumTMQC-8-30-HELIX2019-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886704080121GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080138GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080145GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080152GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080206GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080213GALAXY G3Cerenovus, Inc.KRD2017-11-03
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
10886704077077DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077176DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077183DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077299DELTAXSFTCerenovus, Inc.KRD2016-11-16
10886704077374DELTAXSFTCerenovus, Inc.KRD2016-11-16
10886704076933DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076940DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077091DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077114DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077121DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077138DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077145DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077152DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077169DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077190DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077213MICRUSFRAMECerenovus, Inc.KRD2016-11-16
10886704077220DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077237DELTAFILLCerenovus, Inc.KRD2016-11-16