The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Delee Suction Catheter Code No 533.
| Device ID | K851473 |
| 510k Number | K851473 |
| Device Name: | VYGON DELEE SUCTION CATHETER CODE NO 533 |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Tony J Rivers |
| Correspondent | Tony J Rivers VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-07-15 |