Submission Details
| 510(k) Number | K050109 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 18, 2005 |
| Decision Date | February 11, 2005 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
Feb 2005
Decision
24d
Days
Class 2
Risk
About This 510(k) Submission
K050109 is an FDA 510(k) clearance for the TRILLIUM BIOPUMP PLUS, MODEL BPX80T, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on February 11, 2005, 24 days after receiving the submission on January 18, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.
Device Classification
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4360 |
Manufacturer
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