510(k) K121415
K121415 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "MOLLRING MULTITASC". The FDA issued a decision of Substantially Equivalent on September 5, 2012. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2012
- Date Received
- May 11, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stripper, Artery, Intraluminal
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type