510(k) K253688
- Device
- MEDRAD® Imaging Bulk Package Transfer Spike
- Applicant
- Bayer Medical Care, Inc.
- 510(k) number
- K253688
- Product code
- PQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-12
- Date received
- 2025-11-21
- Regulation
- 880.5440
- Classification name
- Iodinated Contrast Media Transfer Tubing Set
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Troy Jack
- Address
- 1 Bayer Dr. Indianaola PA US 15051 15051
FDA Registration Numbers#
- 3016096098
- 3008692839
- 3004753774
- 1047843
- 3013820501
- 3007829657
- 2520313
- 3011334555
- 1319639
- 1038185
Source Documents#
Other 510(k) Records For Product Code PQH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193010 | Liebel-Flarsheim IBP Transfer Set | Liebel-Flarsheim Company, LLC | 2020-11-18 |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2020-07-30 |
| K173913 | MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC | 2018-05-04 |
| K161723 | ulrich Transfer Set | Ulrich GmbH & Co. KG | 2016-12-21 |
| K133147 | BRACCO INJEENERING TRANSFER SET | Bracco Injeneering S.A. | 2014-06-20 |