Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
FDA 510(k) clearance K183290 · decided 2019-02-25
Clearance details
- K-number
- K183290
- Device name
- Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
- Applicant
- Thrombolex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-26
- Decision date
- 2019-02-25
- Days to decision
- 91 days
- Clearance type
- Traditional
- 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.