The following data is part of a premarket notification filed by Edwards Lifesciences Services Gmbh with the FDA for Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards Aquaspike And Aquasafe.
| Device ID | K063293 |
| 510k Number | K063293 |
| Device Name: | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | EDWARDS LIFESCIENCES SERVICES GMBH BUSINESS & TECHNOLOGY CENTER BESSEMER DRIVE Stevenage, Hertsfordshire, GB Sg1 2dx |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong EDWARDS LIFESCIENCES SERVICES GMBH BUSINESS & TECHNOLOGY CENTER BESSEMER DRIVE Stevenage, Hertsfordshire, GB Sg1 2dx |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2007-03-23 |
| Summary: | summary |