The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Sx Hardshell Reservoir.
| Device ID | K980935 |
| 510k Number | K980935 |
| Device Name: | CAPIOX SX HARDSHELL RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-12 |
| Decision Date | 1998-05-14 |
| Summary: | summary |