The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Premi-cath - Long Term Catheter.
| Device ID | K954302 |
| 510k Number | K954302 |
| Device Name: | VYGON PREMI-CATH - LONG TERM CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-13 |
| Decision Date | 1996-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002332 | K954302 | 000 |
| 30849884002325 | K954302 | 000 |
| 38498840008516 | K954302 | 000 |