The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Capiox Sx18 Oxygenator/ Hardshell Reservoir, Terumo Capiox Sx18 Oxygenator/ Hardshell Reservoir With Xcoating, Terumo Capiox Sx25 Oxygenator/hardshell Reservoir, Terumo Capiox Sx25 Oxygenator/hardshell Reservoir With Xcoating.
| Device ID | K153140 |
| 510k Number | K153140 |
| Device Name: | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir With Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir With Xcoating |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL ROAD Elkton, MD 21921 |
| Contact | Joshua P. Ewing |
| Correspondent | Joshua P. Ewing TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL ROAD Elkton, MD 21921 |
| Product Code | DTZ |
| Subsequent Product Code | DTN |
| Subsequent Product Code | DTP |
| Subsequent Product Code | DTR |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-30 |
| Decision Date | 2015-12-02 |
| Summary: | summary |