510(k) K051421

INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR by Medical Device Technologies, Inc. — Product Code NEU

K051421 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR". The FDA issued a decision of Substantially Equivalent on August 30, 2005. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2005
Date Received
June 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type