MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit— 510(k) K182276
Substantially EquivalentBayer Medical Care, Inc.
FDA 510(k) clearance K182276 for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, Substantially Equivalent on 2018-11-01. Applicant: Bayer Medical Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Bayer Medical Care, Inc.
- Product code
- Code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianaola, PA, US
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- K251788 — Extension tube
More clearances from Bayer Medical Care, Inc.
view all- K253688 — MEDRAD® Imaging Bulk Package Transfer Spike
- K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
- K250893 — Ball Joint Guide Array (66295)
- K200280 — MEDRAD Imaging Bulk Package Transfer Spike
- K192370 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.