DSS Sinusplasty Balloon Catheter

FDA 510(k) K143738 · Intuit Medical Products, LLC

Substantially Equivalent

510(k) numberK143738

Submission

Device name
DSS Sinusplasty Balloon Catheter
Applicant
Intuit Medical Products, LLC
Sugar Hill, GA, US
Received
December 30, 2014
Decision date
August 27, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LRC – Instrument, Ent Manual Surgical
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

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More from Acclarent, Inc.

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Questions and answers

When was DSS Sinusplasty Balloon Catheter cleared by the FDA?

DSS Sinusplasty Balloon Catheter (K143738) received a 510(k) decision of Substantially Equivalent on August 27, 2015, 240 days after the submission was received.

What is the product code of K143738?

The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.