The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Lifecath S Picc And Midline Catheter.
| Device ID | K062425 |
| 510k Number | K062425 |
| Device Name: | LIFECATH S PICC AND MIDLINE CATHETER |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-18 |
| Decision Date | 2006-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002370 | K062425 | 000 |
| 30849884002110 | K062425 | 000 |
| 38498840008547 | K062425 | 000 |
| 38498840008530 | K062425 | 000 |
| 38498840000190 | K062425 | 000 |
| 38498840000183 | K062425 | 000 |