FDA 510(k) clearance · back to tracker

OPTICAL CATHETER(TM) INTRODUCER SETS

Medical Dynamics, Inc. cleared K895041 on 1989-10-16, decision: substantially equivalent

K-number

K895041

Sponsor

Medical Dynamics, Inc.

Device

OPTICAL CATHETER(TM) INTRODUCER SETS

Class

Class I

Decision

Substantially Equivalent

Decision date

1989-10-16

Product code

KGZ

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4200

Official FDA record

Open K895041on 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 K895041 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.