The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Direxion Torqueable Microcatheter.
Device ID | K142259 |
510k Number | K142259 |
Device Name: | Direxion Torqueable Microcatheter |
Classification | Catheter, Continuous Flush |
Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 |
Contact | Mark Lanz |
Correspondent | Mark Lanz BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-14 |
Decision Date | 2014-09-10 |
Summary: | summary |