Submission Details
| 510(k) Number | K220270 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 31, 2022 |
| Decision Date | June 21, 2022 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Aspirex Thrombectomy System
Jun 2022
Decision
141d
Days
Class 2
Risk
About This 510(k) Submission
K220270 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 June 21, 2022, 141 days after receiving the submission on January 31, 2022. 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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