The following data is part of a premarket notification filed by Avalon Laboratories, Llc with the FDA for Avalon Elite Multi-port Venous Femoral Catheter, 20fr, 22fr, 24fr, 26fr, 28fr.
| Device ID | K081933 |
| 510k Number | K081933 |
| Device Name: | AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | AVALON LABORATORIES, LLC 2610 E. HOMESTEAD PLACE Rancho Dominguez, CA 90220 |
| Contact | Lee Wirth |
| Correspondent | Lee Wirth AVALON LABORATORIES, LLC 2610 E. HOMESTEAD PLACE Rancho Dominguez, CA 90220 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2008-10-03 |
| Summary: | summary |