510(k) K040447
K040447 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088". The FDA issued a decision of Substantially Equivalent on March 12, 2004. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2004
- Date Received
- February 20, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Biliary Mechanical
- Device Class
- Class II
- Regulation Number
- 876.4500
- Review Panel
- GU
- Submission Type