The following data is part of a premarket notification filed by Interrad Medical Inc with the FDA for Securacath.
Device ID | K180769 |
510k Number | K180769 |
Device Name: | SecurAcath |
Classification | Implanted Subcutaneous Securement Catheter |
Applicant | Interrad Medical Inc 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 |
Contact | Denise Lenz |
Correspondent | Denise Lenz Libra Medical, Inc 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 |
Product Code | OKC |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-23 |
Decision Date | 2018-06-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SECURACATH 85591187 4348913 Live/Registered |
Interrad Medical, Inc. 2012-04-06 |
SECURACATH 78703147 4071317 Live/Registered |
Interrad Medical, Inc. 2005-08-30 |
SECURACATH 74353255 1813589 Dead/Cancelled |
HDC, Inc. 1993-01-28 |