K253688
- 510(k) number
- K253688
- Device name
- MEDRAD® Imaging Bulk Package Transfer Spike
- Applicant
- Bayer Medical Care, Inc. PA · US
- Product code
- PQH — Iodinated Contrast Media Transfer Tubing Set
- Decision date
- 2026-06-12
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253688.pdf
Official FDA record: K253688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.