Submission Details
| 510(k) Number | K143583 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2014 |
| Decision Date | August 11, 2015 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cathivex ?GV filter units
Aug 2015
Decision
236d
Days
Class 2
Risk
About This 510(k) Submission
K143583 is an FDA 510(k) clearance for the Cathivex ?GV filter units, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Merck Millipore , Ltd. (Carrigtwohill, IE). The FDA issued a Cleared decision on August 11, 2015, 236 days after receiving the submission on December 18, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
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