The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for Supercross Microcatheter, Supercross Ft Microcatheter, Supercross At Microcatheter.
Device ID | K210647 |
510k Number | K210647 |
Device Name: | SuperCross Microcatheter, SuperCross FT Microcatheter, SuperCross AT Microcatheter |
Classification | Catheter, Percutaneous |
Applicant | Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 |
Contact | Steph Pahl |
Correspondent | Steph Pahl Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-03 |
Decision Date | 2021-04-30 |