The following data is part of a premarket notification filed by Access Vascular, Inc with the FDA for Hydropicc.
| Device ID | K172885 |
| 510k Number | K172885 |
| Device Name: | HydroPICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Access Vascular, Inc 175 Middlesex Turnpike Bedford, MA 01730 |
| Contact | Elizabeth Kinnal |
| Correspondent | Elizabeth Kinnal Access Vascular, Inc 175 Middlesex Turnpike Bedford, MA 01730 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2018-02-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HYDROPICC 87388313 5776089 Live/Registered |
Access Vascular, Inc. 2017-03-28 |