FDA 510(k) clearance · back to tracker

MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS

Quinton, Inc. cleared K892450 on 1989-10-11, decision: substantially equivalent

K-number

K892450

Sponsor

Quinton, Inc.

Device

MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS

Class

Class I

Decision

Substantially Equivalent

Decision date

1989-10-11

Product code

KGX

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.5240

Official FDA record

Open K892450on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

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