Submission Details
| 510(k) Number | K193028 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2019 |
| Decision Date | December 05, 2019 |
| Days to Decision | 36 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
MEDRAD Mark 7 Arterion Injection System
Dec 2019
Decision
36d
Days
Class 2
Risk
About This 510(k) Submission
K193028 is an FDA 510(k) clearance for the MEDRAD Mark 7 Arterion Injection System, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on December 5, 2019, 36 days after receiving the submission on October 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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