The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Pressure Isolator.
| Device ID | K092644 |
| 510k Number | K092644 |
| Device Name: | TERUMO PRESSURE ISOLATOR |
| Classification | Transducer, Blood-pressure, Extravascular |
| 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 | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-08-27 |
| Decision Date | 2009-12-10 |
| Summary: | summary |