The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Multi-med Central Venous Catheters, Models: M3720hkic, M4820hkic.
| Device ID | K091709 |
| 510k Number | K091709 |
| Device Name: | MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Jason Smith |
| Correspondent | Jason Smith EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-10-13 |
| Summary: | summary |