← Back to catalogue

Acclarent Se Inflation Device

FDA UDI

Class I (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name
ACCLARENT SE INFLATION DEVICE FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
ACCLARENT SE INFLATION DEVICE, 1 PK FDA UDI
Model / Reference
SEID FDA UDI
Description
ACCLARENT SE INFLATION DEVICE, 1 PK FDA UDI

Identifiers

Catalog Number
SEID FDA UDI
Primary DI / UDI-DI
20705031230863 FDA UDI
510(k) Number
K150172 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Catheter/overtube balloon inflator, single-use

Acclarent Se Inflation Device by Acclarent, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Cleared under the same submission

K150172 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Acclarent, Inc.

Sources (1)

  • FDA UDI b5a5ba86-75cd-4831-b0be-ccb6021e402e 37 fields · synced May 31, 2026