Submission Details
| 510(k) Number | K082905 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2008 |
| Decision Date | January 12, 2009 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
Jan 2009
Decision
104d
Days
Class 2
Risk
About This 510(k) Submission
K082905 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC, 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 January 12, 2009, 104 days after receiving the submission on September 30, 2008. 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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