BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter— 510(k) K231653
Substantially EquivalentThrombolex, Inc.
FDA 510(k) clearance K231653 for BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter, Substantially Equivalent on 2023-07-03. Applicant: Thrombolex, Inc.. Device class: 2.
Clearance details
- Applicant
- Thrombolex, Inc.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- New Britain, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.