Submission Details
| 510(k) Number | K021345 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | April 29, 2002 |
| Decision Date | June 28, 2002 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Jun 2002
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K021345 is an FDA 510(k) clearance for the MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on June 28, 2002, 60 days after receiving the submission on April 29, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
Device Classification
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5010 |
Manufacturer
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