Identity
- Trade Name
- INT FDA UDI
- Generic Name
- Vascular guidewire introduction sleeve FDA UDI
- Device Name
- Push-click Y connector with 15 cm extension tube, torque device, insertion tool; FDA UDI
- Model / Reference
- YCK119A FDA UDI
- Description
- Push-click Y connector with 15 cm extension tube, torque device, insertion tool; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950900922213 FDA UDI
- 510(k) Number
- K170024 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Vascular guidewire introduction sleeve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
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 — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 1f6f7ded-886d-429f-813f-aa02cc4c2c90 34 fields · synced Jun 8, 2026