The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Crux Snare Filter Retrieval Set.
Device ID | K133681 |
510k Number | K133681 |
Device Name: | CRUX SNARE FILTER RETRIEVAL SET |
Classification | Device, Percutaneous Retrieval |
Applicant | VOLCANO CORPORATION 1 FORTUNE DR Billerica, MA 01821 |
Contact | Elisa Hebb |
Correspondent | Elisa Hebb VOLCANO CORPORATION 1 FORTUNE DR Billerica, MA 01821 |
Product Code | MMX |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-02 |
Decision Date | 2014-01-30 |
Summary: | summary |