DEVICE: Liberant™ (00763000998622)
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If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| 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? |
|---|---|---|---|---|
| 66971 | Thrombectomy suction catheterization kit |
A collection of devices intended to be used during a percutaneous transluminal thrombectomy suction procedure (in conjunction with a syringe or dedicated suction pump system) and which includes a thrombectomy suction catheter and additional devices intended to support catheter introduction and function (e.g., dilator, clot buster, haemostasis valve, aspiration tubing). This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| QEW | Peripheral mechanical thrombectomy with aspiration |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K250787 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Dilator Length: 132 CM |
| Catheter Inner Diameter: 2.24 Millimeter |
| Outer Diameter: 2.8 Millimeter |
| Device Size Text, specify: Clotbuster Length: 131 CM |
| Device Size Text, specify: Dilator Outer Diameter: 2.16 MM |
| Device Size Text, specify: French Size: 8F Long |
| Device Size Text, specify: Clotbuster Outer Diameter: 1.56 MM |
| Catheter Length: 115.0 Centimeter |
Device Record Status
254bbe60-9b4b-48cd-b283-07dd5e7b416a
November 24, 2025
1
November 16, 2025
November 24, 2025
1
November 16, 2025
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