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Map-iT 903603

by Access Point Technologies, Inc.

Ref 903603

Map-iT 903603 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-00818087020336), cleared under FDA 510(k) K160390 on 11 Apr 2016 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00818087020336), 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-00818087020336 Basic UDI-DI 00818087020336UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818087020336 UDI-DI Date3 Nov 2016ListedStatusListed 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-00818087020336 registered 2 Nov 2026 Active
  • FDA 510(k) K160390 decided 11 Apr 2016 Active
  • FDA GUDID UDI-DI 00818087020336 listed 3 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160390
  2. Listed FDA GUDID 00818087020336
  3. Registered EUDAMED B-00818087020336

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  • Withdrawn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
Cardiac mapping catheter, percutaneous, single-use
Model / Ref / Catalog
903603
Primary DI / UDI-DI
00818087020336
Basic UDI-DI
B-00818087020336
510(k) Number
FDA product code
DRF
EMDN code
C020180 Cardiac electrophysiology and mapping devices - accessories
GMDN term
Cardiac mapping catheter, percutaneous, single-use
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
MRI safety
MR Unsafe
Size
Length — 110 Centimeter
Catheter Gauge — 4 French

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: Cardiac mapping catheter, percutaneous, single-use

Cleared under the same submission (K160390)

and 8 more cleared under K160390

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
Other properties (18, all answered No)