Int

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref YCK118BModel YCK, MNYCK, HV-1~HV-9

by Shanghai Kindly Medical Instruments Co., Ltd.

Identity

Trade Name: INT FDA UDI
Generic Name: Vascular guidewire introduction sleeve FDA UDI
Device Name: Y Connector Pack EUDAMED
Push-pull Y connector, torque device, insertion tool; FDA UDI
Model / Reference: YCK118B EUDAMEDFDA UDI
YCK, MNYCK, HV-1~HV-9 EUDAMED
Description: Push-pull Y connector, torque device, insertion tool; FDA UDI

Identifiers

Primary DI / UDI-DI: 06950900922299 EUDAMEDFDA UDI
Basic UDI-DI: 69509009CEYCKQA EUDAMED
510(k) Number: K170024 FDA UDI
FDA Product Code: DTL FDA UDI
EMDN Code: C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
GMDN Term: Vascular guidewire introduction sleeve FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.4290 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vascular guidewire introduction sleeve

Int by Shanghai Kindly Medical Instruments Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guidewire introduction sleeve.

Bracket — Shenzhen Keborui Electronics Co., Ltd · Class I
Bracket — Shenzhen Keborui Electronics Co., Ltd · Class I
6F Benchmark 95cm Straight — PENUMBRA, INC. · Class III
Dale Transducer Holder — Dale Medical Products, Inc. · Class I
Manifold Kit — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
Manifold Kit — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
Y Connector Pack — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
Y Connector Pack — Shanghai INT Medical Instruments Co., Ltd. · Class IIa

Cleared under the same submission

K170024 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shanghai Kindly Medical Instruments Co., Ltd.

Sources (2)

FDA UDI 62ec6bf1-67fb-467a-bd7d-dea8347a0a80 34 fields · synced Jun 18, 2026
EUDAMED aedb1b03-ed9f-4711-b0ef-ab2c059048df 61 fields · synced Jun 18, 2026