Submission Details
| 510(k) Number | K230356 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 09, 2023 |
| Decision Date | March 31, 2023 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Aspirex? Thrombectomy System
Mar 2023
Decision
50d
Days
Class 2
Risk
About This 510(k) Submission
K230356 is an FDA 510(k) clearance for the Aspirex? Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on March 31, 2023, 50 days after receiving the submission on February 9, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | QEW — Peripheral Mechanical Thrombectomy With Aspiration |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration. |
Manufacturer
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