The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Nutriline Catheters.
| Device ID | K051690 |
| 510k Number | K051690 |
| Device Name: | VYGON NUTRILINE CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2005-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884000871 | K051690 | 000 |
| 50849884000868 | K051690 | 000 |
| 30849884000857 | K051690 | 000 |
| 30849884000826 | K051690 | 000 |
| 38498840009469 | K051690 | 000 |
| 38498840009438 | K051690 | 000 |
| 38498840009421 | K051690 | 000 |
| 38498840009407 | K051690 | 000 |