The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Modification To Capiox Flexible Venous Reservoir.
| Device ID | K070839 |
| 510k Number | K070839 |
| Device Name: | MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry Courtney |
| Correspondent | Garry Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-27 |
| Decision Date | 2007-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450207 | K070839 | 000 |
| 50699753450191 | K070839 | 000 |