# K063217: Venatech LP Brachial Introducer System (Antecubital)

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jan 12, 2007 after 80 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VenaTech LP Vena Cava Filter: named in the summary without a submission number
- (no number) Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit: named in the summary without a submission number

## Most influential descendants
- K152765: Venatech Convertible Vena Cava Filter System (2016), 3 descendants of its own
- K162875: Sentry IVC filter (2017), 2 descendants of its own
- K173236: Sentry IVC Filter (2018), 1 descendant of its own
- K181202: Sentry IVC Filter (2018), 0 descendants of its own

## Recalls of this device
- Oct 30, 2007 · Not classified · Z-0264-2008: Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.

## Indications for use
The VenaTechTM LP Brachial Introducer System (Antecubital) is intended for use with the B. Braun Medical VenaTechTM LP Vena Cava Filter.

Source page: https://510kreport.com/device/K063217
Methodology: https://510kreport.com/methodology