FDA.reportPublic FDA data

Laguna Clot Retriever System

Primary DI
00850041053097
Brand
Laguna Clot Retriever System
Company
Innova Vascular, Inc.
Model
LAGUNA14-001
Device description
One (1) Laguna Clot Retriever System: Laguna Clot Retriever and Delivery Sheath
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
00850041053097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041053097008500410530978500410530970850041053097

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy wire-netA device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. 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
00850041053073Malibu Aspiration Catheter SystemMALIBU24-0012024-01-05
00850041053080Laguna Clot Retriever SystemLAGUNA10-0012024-01-05
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