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Cardiac Function Laboratory CFL-M Inca

by Cd Leycom BV

Cardiac Function Laboratory CFL-M Inca (CDL001) is a Class II device made by Cd Leycom BV, cleared under FDA 510(k) K003020 on 11 May 2001 and listed in FDA GUDID since 20 Sep 2023 (UDI-DI 08717953256645), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K003020

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717953256645 UDI-DI Date20 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK003020 Date11 May 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K003020 decided 11 May 2001 Active
  • FDA GUDID UDI-DI 08717953256645 listed 20 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K003020
  2. Listed FDA GUDID 08717953256645

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cardiac Function Laboratory
Generic name
Cardiac mapping system
Model / Ref / Catalog
CFL-M Inca, CDL001
Primary DI / UDI-DI
08717953256645
510(k) Number
FDA product code
DQO
GMDN term
Cardiac mapping system
Device class
Class II
Regulation number
870.1200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system

Other devices from Cd Leycom BV

See all devices from Cd Leycom BV →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)