DEVICE: Concerto Detachable Coil System (00763000307240)
Device Identifier (DI) Information
Concerto Detachable Coil System
NV-10-20-HELIX
Not in Commercial Distribution
Micro Therapeutics, Inc.
NV-10-20-HELIX
Not in Commercial Distribution
Micro Therapeutics, Inc.
COIL NV-10-20-HELIX V07
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60941 | Non-neurovascular embolization coil |
A 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRD | Device, Vascular, for Promoting Embolization |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090046 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 50 Degrees Celsius |
Special Storage Condition, Specify: store in a cool dry place |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
df1a9e7f-fa4f-4b6f-b991-93c2d08ee77a
September 25, 2024
3
September 24, 2020
September 25, 2024
3
September 24, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com