The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Glidesheath Slender.
Device ID | K142183 |
510k Number | K142183 |
Device Name: | GLIDESHEATH SLENDER |
Classification | Introducer, Catheter |
Applicant | Terumo Medical Corporation 950 ELKTON BLVD Elkton, MD 21921 |
Contact | Erin Doyle |
Correspondent | Erin Doyle Terumo Medical Corporation 950 ELKTON BLVD Elkton, MD 21921 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-08 |
Decision Date | 2014-11-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GLIDESHEATH SLENDER 85625677 4597661 Live/Registered |
Terumo Kabushiki Kaisha 2012-05-15 |