FDA 510(k) clearance · back to tracker

EPISTAXIS BALLOON CATHETER WITH PACKING

Ultracell Medical Technologies, Inc. cleared K945554 on 1995-02-17, decision: substantially equivalent

K-number

K945554

Sponsor

Ultracell Medical Technologies, Inc.

Device

EPISTAXIS BALLOON CATHETER WITH PACKING

Class

Class I

Decision

Substantially Equivalent

Decision date

1995-02-17

Product code

EMX

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4100

Official FDA record

Open K945554on 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 K945554 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.