510(k) K070514
K070514 is an FDA 510(k) premarket notification submitted by Aln Implants Chirurgicaux for the device "ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO". The FDA issued a decision of Substantially Equivalent on January 30, 2008. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Aln Implants Chirurgicaux has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2008
- Date Received
- February 22, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Intravascular, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.3375
- Review Panel
- CV
- Submission Type