FDA 510(k) clearance · back to tracker

MEDTRONIC A2 CLINICAL IMAGING SYSTEM

Medtronic Vascular cleared K811187 on 1981-05-27, decision: substantially equivalent

K-number

K811187

Sponsor

Medtronic Vascular

Device

MEDTRONIC A2 CLINICAL IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

1981-05-27

Product code

IYX

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1100

Official FDA record

Open K811187on 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.