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
Code	Name
DQY	Catheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
DQY	Catheter, Percutaneous	Cardiovascular	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K240384	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K240384	000	SENDERO Microcatheter	Okami Medical, Inc.	2024-03-08	DQY

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00850008222078	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00850008222078	00850008222078	850008222078	0850008222078

GMDN Terms#

Term, Definition table
Term	Definition
Vascular microcatheter	A 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 DI	Brand	Model	Published
00850008222092	LOBO	LOBO-3-LP	2026-05-19
00850008222085	SENDERO	SENDERO-MAX55-110MP	2025-04-24
00850008222030	LOBO	LOBO-7	2022-06-28
00850008222061	LOBO	LOBO-9	2022-06-28
00850008222009	LOBO	LOBO-HP	2020-01-07
00850008222054	LOBO	LOBO-5	2021-02-09
00850008222016	LOBO	LOBO-3	2020-01-07

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
06934955914713	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914720	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914737	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914744	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914751	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914768	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914775	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914782	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914799	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914805	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914812	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914829	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914836	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914843	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914850	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914867	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914874	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914881	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914898	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914904	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914911	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
06934955914928	Teleport Glide Microcatheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	DQY	2026-07-20
00810024671885	CPS Locator 3D, Small Delivery Catheter	CENTERPOINT SYSTEMS LLC	DQY	2026-07-13
00810024671892	CPS Locator 3D, Medium Delivery Catheter	CENTERPOINT SYSTEMS LLC	DQY	2026-07-13
00810024671908	CPS Locator 3D, Large Delivery Catheter	CENTERPOINT SYSTEMS LLC	DQY	2026-07-13
00810024671915	CPS Locator 3D, Medium, Extra Long Delivery Catheter	CENTERPOINT SYSTEMS LLC	DQY	2026-07-13
00810024671922	CPS Locator 3D, Large, Extra Long Delivery Catheter	CENTERPOINT SYSTEMS LLC	DQY	2026-07-13
00853799007930	8F Base Camp System 2.0 90cm	ROUTE 92 MEDICAL	DQY	2026-07-08
10801902218732	ARROW	TELEFLEX INCORPORATED	DQY	2026-06-24
00810024671953	SSPC NXT Delivery Catheter	CENTERPOINT SYSTEMS LLC	DQY	2026-06-01

SENDERO

Related Records#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Sterilization Methods#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#