Submission Details
| 510(k) Number | K081997 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 14, 2008 |
| Decision Date | October 09, 2008 |
| Days to Decision | 87 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
PERFADEX WITH THAM
Oct 2008
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K081997 is an FDA 510(k) clearance for the PERFADEX WITH THAM, a System And Accessories, Isolated Heart, Transport And Preservation (Class II — Special Controls, product code MSB), submitted by Vitrolife Sweden AB (Kungsbacka, SE). The FDA issued a Cleared decision on October 9, 2008, 87 days after receiving the submission on July 14, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.
Device Classification
| Product Code | MSB — System And Accessories, Isolated Heart, Transport And Preservation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5880 |
Manufacturer
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