The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Multi-med Central Venous Catheters (cvcs), With And Without Heparin Vantex Central Venous Catheters (cvcs), With Heparin.
| Device ID | K113565 |
| 510k Number | K113565 |
| Device Name: | MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Margueite Thomlinson |
| Correspondent | Margueite Thomlinson EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-02 |
| Decision Date | 2012-05-18 |
| Summary: | summary |