BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
FDA 510(k) clearance K231653 · decided 2023-07-03
Clearance details
- K-number
- K231653
- Device name
- BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
- Applicant
- Thrombolex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-06
- Decision date
- 2023-07-03
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- New Britain, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.