FDA.reportPublic FDA data

Malibu Aspiration Catheter System

Primary DI
00850041053073
Brand
Malibu Aspiration Catheter System
Company
Innova Vascular, Inc.
Model
MALIBU24-001
Device description
One (1) Malibu Aspiration Catheter System: Malibu Aspiration Catheter, Dilator, and Syringe
Published
2024-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041053073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041053073008500410530738500410530730850041053073

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterization kitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118406653
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00850041053004Malibu Aspiration Catheter SystemMALIBU24A-0012024-01-05
00850041053011Malibu Aspiration Catheter SystemMALIBU20A-0012024-01-05
00850041053028Malibu Aspiration Catheter SystemMALIBU16A-0012024-01-05
00850041053035Malibu Aspiration Catheter SystemMALIBU12A-0012024-01-05
00850041053042Malibu Aspiration Catheter SystemMALIBU12-0012024-01-05
00850041053059Malibu Aspiration Catheter SystemMALIBU16-0012024-01-05
00850041053066Malibu Aspiration Catheter SystemMALIBU20-0012024-01-05
00850041053080Laguna Clot Retriever SystemLAGUNA10-0012024-01-05
00850041053097Laguna Clot Retriever SystemLAGUNA14-0012024-01-05
00850041053103Laguna Clot Retriever SystemLAGUNA10A-0012024-01-05
00850041053110Laguna Clot Retriever SystemLAGUNA14A-0012024-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169722213Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722220Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722237Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722244Indigo SystemPENUMBRA, INC.QEW2026-03-10
M917RVHD1RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
00810123710249Artix AXINARI MEDICAL INCQEW2026-01-06
00810123710256Artix AXINARI MEDICAL INCQEW2026-01-06
00810169722480Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722497Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722503Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722510Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722527Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722534Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722541Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722558Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00763000849801Liberant™MEDTRONIC, INC.QEW2025-11-16
00763000998615Liberant™MEDTRONIC, INC.QEW2025-11-16
00763000998622Liberant™MEDTRONIC, INC.QEW2025-11-16
00763000998639Liberant™MEDTRONIC, INC.QEW2025-11-16
00763000998646Liberant™MEDTRONIC, INC.QEW2025-11-16
00860009303447Aventus Thrombectomy SystemInquis Medical, Inc.QEW2025-08-20
00810169722466Indigo SystemPENUMBRA, INC.QEW2025-08-19
00810169722473Indigo SystemPENUMBRA, INC.QEW2025-08-19
00851616007668Excipio® LV PRIME Thrombectomy DeviceContego Medical, Inc.QEW2025-07-25
00810123710126InThrill Thrombectomy CatheterINARI MEDICAL INCQEW2025-05-30
00810123710294InThrill SheathINARI MEDICAL INCQEW2025-05-30
00810123710393ClotTriever BOLD CatheterINARI MEDICAL INCQEW2025-04-09
00850291007352InThrill Thrombectomy CatheterINARI MEDICAL INCQEW2024-12-20
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13