The following data is part of a premarket notification filed by Merit Medical Systems Inc. with the FDA for Advocate Pta Catheter.
| Device ID | K192907 |
| 510k Number | K192907 |
| Device Name: | Advocate PTA Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Merit Medical Systems Inc. Parkmore Business Park West Galway, IE N-a |
| Contact | Mark Mullaney |
| Correspondent | Michael O'sullivan Merit Medical Systems Inc. Parkmore Business Park West Galway, IE N-a |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2019-11-26 |
| Summary: | summary |