The following data is part of a premarket notification filed by Nexstep Medical with the FDA for All’incath 035m Pta Balloon Dilatation Catheter.
| Device ID | K191275 |
| 510k Number | K191275 |
| Device Name: | All’InCath 035M PTA Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | NexStep Medical 7-9 Place Saint Bernard Dijon, FR 21000 |
| Contact | Angela Mallery |
| Correspondent | Angela Mallery NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Cardiovascular |
| 510k Review Panel | Cardiovascular |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2020-01-15 |