FDA 510(k) clearance · back to tracker

DSS Sinusplasty Balloon Catheter

Intuit Medical Products, LLC cleared K143738 on 2015-08-27, decision: substantially equivalent

K-number

K143738

Sponsor

Intuit Medical Products, LLC

Device

DSS Sinusplasty Balloon Catheter

Class

Class I

Decision

Substantially Equivalent

Decision date

2015-08-27

Product code

LRC

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4420

Official FDA record

Open K143738on 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.

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Drop K143738 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.

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Source

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