NuVent ™ 1830517SPH

by Medtronic Xomed Inc 2 variants

NuVent ™ 1830517SPH 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 9 Sep 2017 (UDI-DI 00643169770928), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00643169770928 UDI-DI	Date9 Sep 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK152121	Date1 Dec 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00643169770928
FDA 510(k) database 510(k) number K152121

Across registries

2 registries list this device

FDA 510(k) K152121 decided 1 Dec 2015 Active
FDA GUDID UDI-DI 00643169770928 listed 9 Sep 2017 Listed

Timeline

2 dated events

1 Dec 2015 Cleared FDA 510(k) K152121
9 Sep 2017 Listed FDA GUDID 00643169770928

Coverage

1 jurisdiction

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Withdrawn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: 1830517SPH

Primary DI / UDI-DI: 00643169770928
510(k) Number: K152121
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

Size: Length — 17.0 Millimeter
Outer Diameter — 5.0 Millimeter

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number

Other properties (11, all answered No)