The following data is part of a premarket notification filed by Micromedical Solutions, Inc. with the FDA for Mms Pta Balloon Catheter.
| Device ID | K152934 |
| 510k Number | K152934 |
| Device Name: | MMS PTA Balloon Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-05 |
| Decision Date | 2016-04-25 |
| Summary: | summary |