Submission Details
| 510(k) Number | K023591 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 2002 |
| Decision Date | June 18, 2003 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
ULTRA HIGH PRESSURE INJECTOR LINES
Jun 2003
Decision
236d
Days
Class 2
Risk
About This 510(k) Submission
K023591 is an FDA 510(k) clearance for the ULTRA HIGH PRESSURE INJECTOR LINES, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on June 18, 2003, 236 days after receiving the submission on October 25, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
Manufacturer
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