The following data is part of a premarket notification filed by Vygon Usa with the FDA for Vygon Piccs.
| Device ID | K172899 |
| 510k Number | K172899 |
| Device Name: | Vygon PICCs |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Vygon USA 2750 Morris Rd Suite A200 Lansdale, PA 19460 |
| Contact | Jillian Mikovich |
| Correspondent | Jillian Mikovich Vygon USA 2750 Morris Rd Suite A200 Lansdale, PA 19460 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2018-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884001090 | K172899 | 000 |
| 00849884005448 | K172899 | 000 |
| 30849884005012 | K172899 | 000 |
| 30849884005029 | K172899 | 000 |
| 30849884004947 | K172899 | 000 |
| 30849884004954 | K172899 | 000 |
| 30849884004961 | K172899 | 000 |
| 30849884001014 | K172899 | 000 |
| 30849884001021 | K172899 | 000 |
| 30849884001045 | K172899 | 000 |
| 30849884001052 | K172899 | 000 |
| 30849884001076 | K172899 | 000 |
| 30849884001083 | K172899 | 000 |
| 30849884001106 | K172899 | 000 |
| 30849884001007 | K172899 | 000 |
| 30849884001038 | K172899 | 000 |
| 30849884001069 | K172899 | 000 |
| 30849884006231 | K172899 | 000 |