Submission Details
| 510(k) Number | K192370 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 2019 |
| Decision Date | December 13, 2019 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
Dec 2019
Decision
105d
Days
Class 2
Risk
About This 510(k) Submission
K192370 is an FDA 510(k) clearance for the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Bayer Medical Care, Inc. (Whippany, US). The FDA issued a Cleared decision on December 13, 2019, 105 days after receiving the submission on August 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.
Device Classification
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1650 |
Manufacturer
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