The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Cdi Blood Parameter Monitoring System 500.
| Device ID | K133658 |
| 510k Number | K133658 |
| Device Name: | CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Kevin Kong |
| Correspondent | Kevin Kong TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-11-27 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753270164 | K133658 | 000 |
| 00886799000397 | K133658 | 000 |
| 00886799000403 | K133658 | 000 |
| 00886799000410 | K133658 | 000 |
| 00886799001615 | K133658 | 000 |
| 00886799001622 | K133658 | 000 |
| 00886799001639 | K133658 | 000 |
| 00886799001646 | K133658 | 000 |
| 00886799001738 | K133658 | 000 |
| 50699753160762 | K133658 | 000 |
| 50699753269021 | K133658 | 000 |
| 50699753269038 | K133658 | 000 |
| 50699753269045 | K133658 | 000 |
| 50699753270119 | K133658 | 000 |
| 50699753270126 | K133658 | 000 |
| 50699753270133 | K133658 | 000 |
| 50699753270140 | K133658 | 000 |
| 50699753270157 | K133658 | 000 |
| 00886799000007 | K133658 | 000 |