Skip to content

Map-iT 903608

by Access Point Technologies, Inc.

Ref 903608

Map-iT 903608 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 2 Nov 2026 (Basic UDI-DI B-00818083015961), cleared under FDA 510(k) K160390 on 11 Apr 2016 and listed in FDA GUDID since 25 Jun 2019 (UDI-DI 00818083015961), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160390

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00818083015961 Basic UDI-DI 00818083015961UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818083015961 UDI-DI Date25 Jun 2019ListedStatusListed 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-00818083015961 registered 2 Nov 2026 Active
  • FDA 510(k) K160390 decided 11 Apr 2016 Active
  • FDA GUDID UDI-DI 00818083015961 listed 25 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160390
  2. Listed FDA GUDID 00818083015961
  3. Registered EUDAMED B-00818083015961

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  • Withdrawn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
903608
Primary DI / UDI-DI
00818083015961
Basic UDI-DI
B-00818083015961
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 — 4 French
Length — 110 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)