The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Gas Filter.
| Device ID | K021020 |
| 510k Number | K021020 |
| Device Name: | TERUMO GAS FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-06-10 |
| Summary: | summary |