MEDRAD® Imaging Bulk Package Transfer Spike— 510(k) K253688
Substantially EquivalentBayer 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.. Device class: 2.
Summary
Bayer Medical Care's MEDRAD Imaging Bulk Package Transfer Spike is filed under PQH, iodinated contrast media transfer tubing sets. The record gives no model numbers or description beyond the name.
Class II, 21 CFR 880.5440. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
Bayer filed from Indianaola, Pennsylvania, as the record spells the town. The decision came 203 calendar days after FDA received it (November 21, 2025 to June 12, 2026).
Clearance details
- Applicant
- Bayer Medical Care, Inc.
- Product code
- Product code PQH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianaola, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.