Submission Details
| 510(k) Number | K081156 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2008 |
| Decision Date | July 18, 2008 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
CADD MEDICATION CASSETTE RESERVOIR
Jul 2008
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K081156 is an FDA 510(k) clearance for the CADD MEDICATION CASSETTE RESERVOIR, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 18, 2008, 86 days after receiving the submission on April 23, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
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