The following data is part of a premarket notification filed by Vygon Usa with the FDA for Vygon Midline 3 Fr Sl Catheter; Vygon Midline 4 Fr Sl Catheter; Vygon Midline 5 Fr Dl Catheter.
| Device ID | K181208 |
| 510k Number | K181208 |
| Device Name: | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter |
| Classification | Midline Catheter |
| 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 | PND |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884004916 | K181208 | 000 |
| 30849884005456 | K181208 | 000 |
| 30849884005067 | K181208 | 000 |
| 30849884005159 | K181208 | 000 |
| 30849884005005 | K181208 | 000 |
| 30849884004930 | K181208 | 000 |
| 30849884000949 | K181208 | 000 |
| 30849884000956 | K181208 | 000 |
| 30849884000963 | K181208 | 000 |
| 30849884000970 | K181208 | 000 |
| 30849884000987 | K181208 | 000 |
| 30849884000994 | K181208 | 000 |
| 30849884004855 | K181208 | 000 |
| 30849884004862 | K181208 | 000 |
| 30849884005425 | K181208 | 000 |