LEMAITRE EMBOLECTOMY CATHETER
FDA 510(k) clearance K992368 · decided 1999-12-09
Clearance details
- K-number
- K992368
- Device name
- LEMAITRE EMBOLECTOMY CATHETER
- Applicant
- Vascutech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-15
- Decision date
- 1999-12-09
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DXE
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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