510(k) K073374
K073374 is an FDA 510(k) premarket notification submitted by William Cook Europe Aps for the device "COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET". The FDA issued a decision of Substantially Equivalent on March 7, 2008. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. William Cook Europe Aps has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2008
- Date Received
- December 3, 2007
- Clearance Type
- Traditional
- 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