FDA 510(k) clearance · back to tracker

Drivewire 35 Guidewire

Rapid Medical Ltd. cleared K254006 on 2026-07-17, decision: substantially equivalent

K-number

K254006

Sponsor

Rapid Medical Ltd.

Device

Drivewire 35 Guidewire

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-17

Product code

MOF

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1330

Official FDA record

Open K254006on 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 K254006 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.