Submission Details
| 510(k) Number | K061958 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 2006 |
| Decision Date | September 05, 2006 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MEDTRONIC EXPORT XT CATHETER
Sep 2006
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K061958 is an FDA 510(k) clearance for the MEDTRONIC EXPORT XT CATHETER, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on September 5, 2006, 56 days after receiving the submission on July 11, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | QEZ — Aspiration Thrombectomy Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration. |
Manufacturer
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