The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Hx2 Temperature Management System.
| Device ID | K071521 |
| 510k Number | K071521 |
| Device Name: | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Mark A Bur |
| Correspondent | Mark A Bur TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-04 |
| Decision Date | 2007-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886799000908 | K071521 | 000 |