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 |