The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Xcela Power Injectable Picc.
| Device ID | K150527 |
| 510k Number | K150527 |
| Device Name: | Xcela Power Injectable PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Wanda Carpinella |
| Correspondent | Wanda Carpinella NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-03-31 |
| Summary: | summary |