M-Y Sheath
Introducer, Catheter
RAM Medical Innovations, Inc.
The following data is part of a premarket notification filed by Ram Medical Innovations, Inc. with the FDA for M-y Sheath.
Pre-market Notification Details
| Device ID | K190369 |
| 510k Number | K190369 |
| Device Name: | M-Y Sheath |
| Classification | Introducer, Catheter |
| Applicant | RAM Medical Innovations, Inc. 326 Braytonburne Drive Springfield, OH 45503 |
| Contact | Mubin Syed |
| Correspondent | Lloyd H Griese LamaMed Solutions, Inc. 709 Sandoval Way Hayward, CA 94544 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-04-17 |
Trademark Results [M-Y Sheath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M-Y SHEATH 87289167 not registered Dead/Abandoned |
RAM Medical Innovations LLC 2017-01-04 |
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