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NuVent 1830616EST

by Medtronic Xomed Inc

NuVent 1830616EST is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K210841 on 16 Aug 2021 and listed in FDA GUDID since 4 Oct 2021 (UDI-DI 00763000416034), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K210841

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000416034 UDI-DI Date4 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210841 Date16 Aug 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210841 decided 16 Aug 2021 Active
  • FDA GUDID UDI-DI 00763000416034 listed 4 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210841
  2. Listed FDA GUDID 00763000416034

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NuVent
Generic name
Eustachian catheter, single-use
Model / reference
1830616EST
Primary DI / UDI-DI
00763000416034
510(k) Number
FDA product code
PNZ
GMDN term
Eustachian catheter, single-use
Device class
Class II
Regulation number
874.4180
GUDID distribution status
In Commercial Distribution

Related devices

Category: Eustachian catheter, 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 (11, all answered No)