Skip to content

NuVent™ 18INFKIT

by Medtronic Xomed Inc

Ref 18INFKIT

NuVent™ 18INFKIT is a Class I device made by Medtronic Xomed Inc, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 0763000B000211278), cleared under FDA 510(k) K152121 on 1 Dec 2015 and listed in FDA GUDID since 15 Aug 2025 (UDI-DI 00763000745080), active as of 8 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152121

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000211278 Basic UDI-DI 00763000745080UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000745080 UDI-DI Date15 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152121 Date1 Dec 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000211278 registered 28 Sep 2026 Active
  • FDA 510(k) K152121 decided 1 Dec 2015 Active
  • FDA GUDID UDI-DI 00763000745080 listed 15 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152121
  2. Listed FDA GUDID 00763000745080
  3. Registered EUDAMED 0763000B000211278

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
NuVent™
Generic name
Catheter/overtube balloon inflator, single-use
Device name
NuVent Inflator Kit
Model / reference
18INFKIT
Primary DI / UDI-DI
00763000745080
Basic UDI-DI
0763000B000211278
510(k) Number
FDA product code
LRC
EMDN code
Q030308 ENT surgery dilators, single-use
GMDN term
Catheter/overtube balloon inflator, single-use
Device class
Class I
Regulation number
874.4420
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Catheter/overtube balloon inflator, single-use

Cleared under the same submission (K152121)

and 8 more cleared under K152121

Similar devices in this category

Other devices filed under ENT SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)