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INT, K2 Microcatheter MCS02-1

by Shanghai Kindly Medical Instruments Co., Ltd.

INT, K2 Microcatheter MCS02-1 is a Class II device made by Shanghai Kindly Medical Instruments Co., Ltd., registered in EUDAMED, cleared under FDA 510(k) K201706 and listed in FDA GUDID since 29 Aug 2023 (UDI-DI 06950900934285), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201706↗

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06950900934285 UDI-DI Date29 Aug 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK201706 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Active· +1 more in the status table
  • FDA 510(k) K201706 Active
  • FDA GUDID UDI-DI 06950900934285 listed 29 Aug 2023 Listed

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
INT,K2 Microcatheter
Generic name
Coronary artery infusion catheter
Model / reference
MCS02-1
Primary DI / UDI-DI
06950900934285
510(k) Number
FDA product code
DQY
GMDN term
Coronary artery infusion catheter
Device class
Class II
Regulation number
870.1250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coronary artery infusion catheter

Cleared under the same submission (K201706)

and 8 more cleared under K201706

Similar devices

Other devices filed under FDA product code DQY (Catheter, Percutaneous).

Other devices from Shanghai Kindly Medical Instruments Co., Ltd.

See all devices from Shanghai Kindly Medical Instruments Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)