MEDRAD Imaging Bulk Package Transfer Spike
FDA 510(k) K200280 · Bayer Medical Care, Inc.
510(k) numberK200280
Submission
- Device name
- MEDRAD Imaging Bulk Package Transfer Spike
- Applicant
- Bayer Medical Care, Inc.
Indianaola, PA, US - Received
- February 4, 2020
- Decision date
- July 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PQH – Iodinated Contrast Media Transfer Tubing Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment. The transfer set is intended to be used to directly fill multiple sterile single use syringes from an imaging bulk package contrast media bulk package under controlled ambient filling conditions such as a CT suite.
Other 510(k)s with product code PQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer SpikePQH · Traditional | Bayer Medical Care, Inc. | 06/12/2026SE |
| K193010 | Liebel-Flarsheim IBP Transfer SetPQH · Traditional | Liebel-Flarsheim Company, LLC | 11/18/2020SE |
| K173913 | MEDRAD® Imaging Bulk Package Transfer SetPQH · Traditional | Bayer U.S., LLC | 05/04/2018SE |
| K161723 | ulrich Transfer SetPQH · Traditional | Ulrich GmbH & Co. KG | 12/21/2016SE |
| K133147 | Bracco Injeenering Transfer SetPQH · Traditional | Bracco Injeneering S.A. | 06/20/2014SE |
More from Bracco Injeneering S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer SpikePQH · Traditional | 06/12/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | 02/13/2026SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | 09/04/2025SE |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationDXT · Traditional | 12/13/2019SE |
| K193028 | MEDRAD Mark 7 Arterion Injection SystemDXT · Special | 12/05/2019SE |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitDXT · Special | 11/01/2018SE |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Special | 11/01/2018SE |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Traditional | 08/17/2018SE |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe KitDXT · Traditional | 08/14/2015SE |
Questions and answers
When was MEDRAD Imaging Bulk Package Transfer Spike cleared by the FDA?
MEDRAD Imaging Bulk Package Transfer Spike (K200280) received a 510(k) decision of Substantially Equivalent on July 30, 2020, 177 days after the submission was received.
What is the product code of K200280?
The FDA product code is PQH – Iodinated Contrast Media Transfer Tubing Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.