Identity
- Trade Name
- INT FDA UDI
- Generic Name
- Vascular guidewire introduction sleeve FDA UDI
- Device Name
- Y Connector Pack EUDAMEDScrew type Y connector with 15 cm extension tube, 45 psi stopcock,torque device, insertion tool; FDA UDI
- Model / Reference
- YCK111A EUDAMEDFDA UDIYCK, MNYCK, HV-1~HV-9 EUDAMED
- Description
- Screw type Y connector with 15 cm extension tube, 45 psi stopcock,torque device, insertion tool; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950900921858 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 EUDAMEDClass 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
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:
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- Y CONNECTOR KIT — VALFLUX GROUP, LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Kindly Medical Instruments Co., Ltd.
Sources (2)
- FDA UDI 6576531f-5df5-4f65-9b29-42b5d802ea2b 34 fields · synced Jun 18, 2026
- EUDAMED cc21ad4f-96c8-4108-aad4-5df65e6aad99 61 fields · synced Jun 18, 2026