The following data is part of a premarket notification filed by Avalon Laboratories, Llc with the FDA for Avalon Elite Bi-caval Dual Lumen Catheter, 13fr, 16fr, 19fr, 20fr, 23fr, 27fr, 31fr.
| Device ID | K081820 |
| 510k Number | K081820 |
| Device Name: | AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | AVALON LABORATORIES, LLC 5200 CRYSTAL WATER DR. Austin, TX 78735 |
| Contact | David C Furr |
| Correspondent | David C Furr AVALON LABORATORIES, LLC 5200 CRYSTAL WATER DR. Austin, TX 78735 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-27 |
| Decision Date | 2008-10-06 |
| Summary: | summary |