510(k) K133147
- Device
- BRACCO INJEENERING TRANSFER SET
- Applicant
- BRACCO INJENEERING S.A.
- 510(k) number
- K133147
- Product code
- PQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-20
- Date received
- 2013-10-17
- 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
- No
Applicant Contact#
- Contact
- THOMAS KROENKE
- Address
- P.O. Box 3018 Nederland CO US 80466 80466
FDA Registration Numbers#
- 3013820501
- 3008692839
- 3016096098
- 1038185
- 1319639
- 1047843
- 3007829657
- 3011334555
- 3004753774
- 2520313
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 |
Legacy Summary#
summary
FDA Review#
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