FDA.reportPublic FDA data

LOBO

Primary DI
00850008222054
Brand
LOBO
Company
OKAMI MEDICAL, INC.
Model
LOBO-5
Device description
Peripheral Vascular Occluder
Published
2021-02-09
Public version status
New
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
K203025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203025000LOBO Vascular Occlusion System (model LOBO-5)Okami Medical2020-11-05KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008222054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008222054008500082220548500082220540850008222054

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, metallicA non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9494469710info@okamimedical.com

Regulatory Flags#

DUNS number
117045423
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008222092LOBOLOBO-3-LP2026-05-19
00850008222085SENDEROSENDERO-MAX55-110MP2025-04-24
00850008222078SENDEROSENDERO-MC29-1302024-04-05
00850008222030LOBOLOBO-72022-06-28
00850008222061LOBOLOBO-92022-06-28
00850008222009LOBOLOBO-HP2020-01-07
00850008222016LOBOLOBO-32020-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000495626Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488284Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488291Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488369Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488420Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488437Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488482Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488642Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488659Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488666Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488697Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488710Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28