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NuVent ™ 1830517FRT70

by Medtronic Xomed Inc

NuVent ™ 1830517FRT70 is a Class I device made by Medtronic Xomed Inc, cleared under FDA 510(k) K152121 on 1 Dec 2015 and listed in FDA GUDID since 10 Sep 2017 (UDI-DI 00643169705302), 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) K152121

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 Number00643169705302 UDI-DI Date10 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152121 Date1 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152121 decided 1 Dec 2015 Active
  • FDA GUDID UDI-DI 00643169705302 listed 10 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152121
  2. Listed FDA GUDID 00643169705302

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  • Withdrawn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
Nasal/paranasal balloon catheter, non-tracking
Model / reference
1830517FRT70
Primary DI / UDI-DI
00643169705302
510(k) Number
FDA product code
LRC
GMDN term
Nasal/paranasal balloon catheter, non-tracking
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal/paranasal balloon catheter

Cleared under the same submission (K152121)

and 8 more cleared under K152121

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)