The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Arterial-venous Fistula Needle Set With Securement Device.
| Device ID | K062953 |
| 510k Number | K062953 |
| Device Name: | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE |
| Classification | Needle, Fistula |
| Applicant | MEDISYSTEMS CORP. 701 PIKE STREET, SUITE 1600 Seattle, WA 98101 -3016 |
| Contact | Fredric Swindler |
| Correspondent | Fredric Swindler MEDISYSTEMS CORP. 701 PIKE STREET, SUITE 1600 Seattle, WA 98101 -3016 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-02-12 |
| Summary: | summary |