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) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-13 |
Decision Date | 2020-01-15 |