The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Terumo Pall Al20x Arterial Filter.
| Device ID | K121209 |
| 510k Number | K121209 |
| Device Name: | TERUMO PALL AL20X ARTERIAL FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Suzanne Grenier |
| Correspondent | Suzanne Grenier Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-20 |
| Decision Date | 2012-05-08 |
| Summary: | summary |