MEDRAD® Imaging Bulk Package Transfer Spike— 510(k) K253688

Substantially Equivalent

Bayer Medical Care, Inc.

FDA 510(k) clearance K253688 for MEDRAD® Imaging Bulk Package Transfer Spike, Substantially Equivalent on 2026-06-12. Applicant: Bayer Medical Care, Inc..

Clearance details

Applicant: Bayer Medical Care, Inc.
Product code: Code PQH
Advisory panel: General Hospital
Date received: 2025-11-21
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianaola, PA, US

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