FDA 510(k) clearance · back to tracker

RELIEVA ULTIRRA Sinus Balloon Catheter

Acclarent, Inc. cleared K190525 on 2019-05-03, decision: substantially equivalent

K-number

K190525

Sponsor

Acclarent, Inc.

Device

RELIEVA ULTIRRA Sinus Balloon Catheter

Class

Class I

Decision

Substantially Equivalent

Decision date

2019-05-03

Product code

LRC

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4420

Official FDA record

Open K190525on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K190525 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.