The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Basixtouch.
Device ID | K130566 |
510k Number | K130566 |
Device Name: | BASIXTOUCH |
Classification | Syringe, Balloon Inflation |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Contact | Dan W Lindsay |
Correspondent | Dan W Lindsay MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Product Code | MAV |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-04 |
Decision Date | 2013-06-19 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BASIXTOUCH 98616374 not registered Live/Pending |
Merit Medical Systems, Inc. 2024-06-24 |