The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Leader-flex.
| Device ID | K052564 |
| 510k Number | K052564 |
| Device Name: | VYGON LEADER-FLEX |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2006-04-05 |
| Summary: | summary |