The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Infinity Ls Plus Long Sheath.
Device ID | K193034 |
510k Number | K193034 |
Device Name: | AXS Infinity LS Plus Long Sheath |
Classification | Catheter, Percutaneous |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
Contact | Shivani H Patel |
Correspondent | Shivani H Patel Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-31 |
Decision Date | 2019-11-29 |
Summary: | summary |