The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Neuroscout Steerable Guidewire.
Device ID | K100351 |
510k Number | K100351 |
Device Name: | NEUROSCOUT STEERABLE GUIDEWIRE |
Classification | Wire, Guide, Catheter |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Joan Bartle |
Correspondent | Joan Bartle Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-02-12 |
Decision Date | 2010-03-16 |
Summary: | summary |