MEDRAD Stellant FLEX CT Injection System with Certegra Workstation— 510(k) K192370
Substantially EquivalentBayer Medical Care, Inc.
FDA 510(k) clearance K192370 for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, Substantially Equivalent on 2019-12-13. 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
- Traditional
- Location
- Whippany, NJ, US
Recent devices under product code DXT
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- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- 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
- K193028 — MEDRAD Mark 7 Arterion Injection System
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 →
Recalls naming K192370
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192370.
Data sourced from openFDA. This site is unofficial and independent of the FDA.