Atlas FDA

VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)

FDA 510(k) clearance K063217 · decided 2007-01-12

Clearance details

K-number
K063217
Device name
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
Applicant
B.Braun Medical, Inc.
Decision
Substantially Equivalent
Date received
2006-10-24
Decision date
2007-01-12
Days to decision
80 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Bethlehem, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun. Man recall (Z-0264-2008)B. Braun Interventional Systems2007-11-24