Submission Details
| 510(k) Number | K192598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Bashir S-B Endovascular Catheter, Ref. No. 7101
Oct 2019
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K192598 is an FDA 510(k) clearance for the Bashir S-B Endovascular Catheter, Ref. No. 7101, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by Thrombolex, Inc. (New Britain, US). The FDA issued a Cleared decision on October 18, 2019, 28 days after receiving the submission on September 20, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | QEY — Mechanical Thrombolysis Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature. |
Manufacturer
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