The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Lectrospiral.
| Device ID | K883612 |
| 510k Number | K883612 |
| Device Name: | LECTROSPIRAL |
| Classification | Set, Administration, Intravascular |
| Applicant | VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Robert G Brooks |
| Correspondent | Robert G Brooks VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-22 |
| Decision Date | 1988-09-29 |