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Map-iT 901146

by Access Point Technologies, Inc.

Ref 901146

Map-iT 901146 is a device classified as Class III in the EU and Class II in the US made by Access Point Technologies, Inc., registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-00818083011741), cleared under FDA 510(k) K160390 on 11 Apr 2016 and listed in FDA GUDID since 19 Oct 2018 (UDI-DI 00818083011741), active as of 23 Oct 2026.

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

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160390

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00818083011741 Basic UDI-DI 00818083011741UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818083011741 UDI-DI Date19 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160390 Date11 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00818083011741 registered 1 Oct 2026 Active
  • FDA 510(k) K160390 decided 11 Apr 2016 Active
  • FDA GUDID UDI-DI 00818083011741 listed 19 Oct 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160390
  2. Listed FDA GUDID 00818083011741
  3. Registered EUDAMED B-00818083011741

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Map-iT Diagnostic Mapping Catheter EUDAMED
Map-iT GUDID
Generic name
Intracardiac catheter-tip electrode
Model / Ref / Catalog
901146
Primary DI / UDI-DI
00818083011741
Basic UDI-DI
B-00818083011741
510(k) Number
FDA product code
DRF
EMDN code
C020180 Cardiac electrophysiology and mapping devices - accessories
GMDN term
Intracardiac catheter-tip electrode
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1220
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 6 French
Length — 65 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Intracardiac catheter-tip electrode

Cleared under the same submission (K160390)

and 8 more cleared under K160390

Similar devices

Also classified as Intracardiac catheter-tip electrode.

Similar devices in this category

Other devices filed under CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES.

Other devices from Access Point Technologies, Ep Inc.

See all devices from Access Point Technologies, Ep Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)