FDA.reportPublic FDA data

ConcertoTM

Primary DI
00847536033481
Brand
ConcertoTM
Company
Micro Therapeutics, Inc.
Model
NV-2-4-HELIX
Device description
COIL NV-2-4-HELIX V06
Published
2019-06-24
Public version status
Update
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
K081465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081465000AXIUM DETACHABLE COIL SYSTEMMicro Therapeutics, Inc.2008-08-19KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536033481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536033481008475360334818475360334810847536033481

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA sterile, 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
Storage Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

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
00763000974077Riptide™MAT-110-1102026-03-30
00763000290702Instant DetacherID-1-52023-01-30
00763000950750Riptide™ Aspiration PumpMAP-10002026-03-09
00763000491772Avyon™ 8FR Balloon Guide Catheter8F-087-85CM2021-04-15
00763000491789Avyon™ 8FR Balloon Guide Catheter8F-087-95CM2021-04-15
00763000915681Riptide™ Aspiration PumpLMT-RAP2025-08-18
00763000925338OnyxTM Liquid Embolic System (LES)105-7100-0602026-01-02
00763000925352OnyxTM Liquid Embolic System (LES)105-7100-0802026-01-02
00847536026834RebarTM105-5081-1532017-04-14
00763000974091Riptide™MAC-12002025-12-13
00763000294236HyperForm104-44202020-08-01
00763000294298HyperForm104-47152020-08-01
00836462002180RebarTM105-5081-1302015-10-09
00847536005471HyperFormTM104-44202016-08-19
00847536005549HyperFormTM104-44702016-04-05
00847536005792HyperFormTM104-47152016-08-14
00836462002197Rebar105-5081-1532015-10-22
00763000294267HyperForm104-44702020-08-01
00763000294328HyperForm104-47702020-08-01
00836462002135Rebar105-5080-1532015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857798005093Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005109Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005123Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005130Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005147Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10841156105655GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105662GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105679GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
07613327578577Target TetraStryker CorporationKRD2022-12-19
07613327578591Target TetraStryker CorporationKRD2022-12-19
07613327578607Target TetraStryker CorporationKRD2022-12-19
07613327578638Target TetraStryker CorporationKRD2022-12-19
07613327578676Target TetraStryker CorporationKRD2022-12-19
07613327578683Target TetraStryker CorporationKRD2022-12-19
07613327578690Target TetraStryker CorporationKRD2022-12-19
07613327578706Target TetraStryker CorporationKRD2022-12-19
07613327578737Target TetraStryker CorporationKRD2022-12-19
07613327578744Target TetraStryker CorporationKRD2022-12-19
07613327580099Target TetraStryker CorporationKRD2022-12-19
10841156106591GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106614GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106621GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106638GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
07613327466386TARGETStryker CorporationKRD2019-09-05
07613327466416TARGETStryker CorporationKRD2019-09-05
07613327466423TARGETStryker CorporationKRD2019-09-05
10841156100001OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100018OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100025OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27
10841156100032OPTISPHERETELEFLEX INCORPORATEDKRD2018-03-27