510(k) K023688

LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER by LeMaitre Vascular, Inc. — Product Code GAF

K023688 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER". The FDA issued a decision of Substantially Equivalent on January 30, 2003. The device falls under product code GAF (Spatula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2003
Date Received
November 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type