The following data is part of a premarket notification filed by Vygon with the FDA for Leaderflex.
| Device ID | K141026 |
| 510k Number | K141026 |
| Device Name: | LEADERFLEX |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VYGON 2750 MORRIS ROAD, SUITE A200 Lansdale, PA 19446 |
| Contact | Jillian Mikovich |
| Correspondent | Jillian Mikovich VYGON 2750 MORRIS ROAD, SUITE A200 Lansdale, PA 19446 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-22 |
| Decision Date | 2014-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884004411 | K141026 | 000 |
| 30849884004985 | K141026 | 000 |
| 50849884001124 | K141026 | 000 |
| 30849884004992 | K141026 | 000 |
| 38498840010021 | K141026 | 000 |
| 38498840010397 | K141026 | 000 |
| 38498840010427 | K141026 | 000 |
| 38498840010434 | K141026 | 000 |
| 30849884005371 | K141026 | 000 |
| 30849884005388 | K141026 | 000 |
| 30849884001113 | K141026 | 000 |
| 30849884003049 | K141026 | 000 |
| 30849884000031 | K141026 | 000 |
| 30849884000048 | K141026 | 000 |
| 30849884000055 | K141026 | 000 |
| 30849884004398 | K141026 | 000 |
| 30849884004404 | K141026 | 000 |
| 30849884005791 | K141026 | 000 |