The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Concierge Guiding Catheter.
Device ID | K121051 |
510k Number | K121051 |
Device Name: | CONCIERGE GUIDING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
Contact | Michaela Rivkowich |
Correspondent | Michaela Rivkowich MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-06 |
Decision Date | 2012-06-13 |
Summary: | summary |