FDA 510(k) clearance · back to tracker

HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE

Baxter Healthcare Corp cleared K895868 on 1989-10-31, decision: substantially equivalent

K-number

K895868

Sponsor

Baxter Healthcare Corp

Device

HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE

Class

Class I

Decision

Substantially Equivalent

Decision date

1989-10-31

Product code

GYK

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4545

Official FDA record

Open K895868on 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 K895868 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.