FDA 510(k) clearance · back to tracker

Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set

Route 92 Medical, Inc. cleared K263266 on 2026-10-16, decision: substantially equivalent

K-number

K263266

Sponsor

Route 92 Medical, Inc.

Device

Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-16

Product code

NRY

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1250

Official FDA record

Open K263266on 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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Raw record →

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.