The following data is part of a premarket notification filed by Micromedical Solutions, Inc. with the FDA for Mms Guide Catheter.
Device ID | K152625 |
510k Number | K152625 |
Device Name: | MMS Guide Catheter |
Classification | Catheter, Continuous Flush |
Applicant | MicroMedical Solutions, Inc. 790 Willard Street #209 Quincy, MA 02169 |
Contact | Gregory Mathison |
Correspondent | Gregory Mathison MicroMedical Solutions, Inc. 790 Willard Street #209 Quincy, MA 02169 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-15 |
Decision Date | 2016-03-09 |
Summary: | summary |