Submission Details
| 510(k) Number | K042784 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 06, 2004 |
| Decision Date | December 10, 2004 |
| Days to Decision | 65 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
Dec 2004
Decision
65d
Days
Class 2
Risk
About This 510(k) Submission
K042784 is an FDA 510(k) clearance for the MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on December 10, 2004, 65 days after receiving the submission on October 6, 2004. This device falls under the Cardiovascular 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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