The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Blood Tubing Accessory With Clave Connector.
| Device ID | K983559 |
| 510k Number | K983559 |
| Device Name: | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Sheryl Saenz |
| Correspondent | Sheryl Saenz ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1998-12-24 |
| Summary: | summary |