FDA.reportPublic FDA data

SENDERO

Primary DI
00850008222078
Brand
SENDERO
Company
OKAMI MEDICAL, INC.
Model
SENDERO-MC29-130
Device description
Microcatheter
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240384000SENDERO MicrocatheterOkami Medical, Inc.2024-03-08DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008222078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008222078008500082220788500082220780850008222078

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Sterilization Methods#

Method table
Method

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
00850008222085SENDEROSENDERO-MAX55-110MP2025-04-24
00850008222092LOBOLOBO-3-LP2026-05-19
00850008222030LOBOLOBO-72022-06-28
00850008222061LOBOLOBO-92022-06-28
00850008222009LOBOLOBO-HP2020-01-07
00850008222054LOBOLOBO-52021-02-09
00850008222016LOBOLOBO-32020-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623352AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationDQY2025-03-04
00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008165ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008172ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008189ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008196ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008202ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008219ZebraQ'APEL MEDICAL LLCDQY2025-01-03