Submission Details
| 510(k) Number | K121776 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 18, 2012 |
| Decision Date | August 14, 2012 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
Aug 2012
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K121776 is an FDA 510(k) clearance for the AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on August 14, 2012, 57 days after receiving the submission on June 18, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
Similar Devices — DQX Wire, Guide, Catheter
All 760
K253262 · Nano4imaging GmbH
· Mar 2026
K253847 · Merit Medical Ireland, Ltd.
· Jan 2026
K251385 · Merit Medical Ireland, Ltd.
· Jan 2026
K252674 · Solo Pace, Inc.
· Jan 2026
K251596 · William Cook Europe Aps
· Nov 2025
K250203 · Sureax Medical, LLC
· Oct 2025
More from Codman & Shurtleff, Inc.
View all
K193380
· NRY · Jul 2020
K191237
· DQY · Nov 2019
K173192
· GWM · Nov 2017
K172537
· JXG · Oct 2017
K172022
· JXG · Oct 2017