Submission Details
| 510(k) Number | K121209 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 2012 |
| Decision Date | May 08, 2012 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
TERUMO PALL AL20X ARTERIAL FILTER
May 2012
Decision
18d
Days
Class 2
Risk
About This 510(k) Submission
K121209 is an FDA 510(k) clearance for the TERUMO PALL AL20X ARTERIAL FILTER, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on May 8, 2012, 18 days after receiving the submission on April 20, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.
Device Classification
| Product Code | DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4260 |
Manufacturer
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