FDA 510(k) clearance · back to tracker

RELIEVA SOLO ELITE SINUS BALLOON CATHETER

Acclarent, Inc. cleared K111254 on 2011-08-22, decision: substantially equivalent

K-number

K111254

Sponsor

Acclarent, Inc.

Device

RELIEVA SOLO ELITE SINUS BALLOON CATHETER

Class

Class I

Decision

Substantially Equivalent

Decision date

2011-08-22

Product code

LRC

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4420

Official FDA record

Open K111254on 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 K111254 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.