INT, K2 Microcatheter

FDA UDI

Class II (US FDA UDI)

by Shanghai Kindly Medical Instruments Co., Ltd.

Identity

Trade Name: INT,K2 Microcatheter FDA UDI
Generic Name: Coronary artery infusion catheter FDA UDI
Device Name: 1.6F-2.3F, 150cm,, curved tip,fully hydrophilic coating FDA UDI
Model / Reference: MCM03-0L FDA UDI
Description: 1.6F-2.3F, 150cm,, curved tip,fully hydrophilic coating FDA UDI

Identifiers

Primary DI / UDI-DI: 06950900998881 FDA UDI
510(k) Number: K201706 FDA UDI
FDA Product Code: DQY FDA UDI
GMDN Term: Coronary artery infusion catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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: Coronary artery infusion catheter

INT, K2 Microcatheter by Shanghai Kindly Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary artery infusion catheter.

Bullfrog Micro-Infusion Device — Mercator MedSystems, Inc. · Class II
LEAPFROG Micro-Infusion Device — Mercator MedSystems, Inc. · Class II
Bullfrog Micro-Infusion Device — Mercator MedSystems, Inc. · Class II
Bullfrog Micro-Infusion Device — Mercator MedSystems, Inc. · Class II
RAYFLOW — Hexacath · Class II
Bullfrog Micro-Infusion Device — Mercator MedSystems, Inc. · Class II
Bullfrog Micro-Infusion Device — Mercator MedSystems, Inc. · Class II
ASAHI SASUKE — ASAHI INTECC CO., LTD. · Class II

Cleared under the same submission

K201706 also covers:

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

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Manufacturer

Manufacturer: Shanghai Kindly Medical Instruments Co., Ltd.

Sources (1)

FDA UDI 241edb96-7b46-4c58-8963-1cf8f8964f82 34 fields · synced May 30, 2026