510(k) · Cleared
Recalled · 2007Venatech LP Brachial Introducer System (Antecubital)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · DTK Filter, Intravascular, Cardiovascular
Cleared on Jan 12, 2007 after an 80-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2007
- Review
- 80 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK063217 Venatech LP Brachial Introducer System (Antecubital)B.Braun Medical, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK152765 Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK173236 Sentry IVC FilterNovate Medical, Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK181202 Sentry IVC FilterNovate Medical, Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K152765Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016 · cites it directly3descendants
- K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 2 generations on2descendants
- K173236Sentry IVC FilterNovate Medical, Ltd. · 2018 · 3 generations on1descendant
- K181202Sentry IVC FilterNovate Medical, Ltd. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063217 | Venatech LP Brachial Introducer System (Antecubital) | B.Braun Medical, Inc. | 2007 | — |
| +1 | K152765 | Venatech Convertible Vena Cava Filter System | B. Braun Interventional Systems, Inc. | 2016 | — |
| +2 | K162875 | Sentry IVC filter | Novate Medical, Ltd. | 2017 | — |
| +3 | K173236 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
| +4 | K181202 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTK device
- #1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | VenaTech LP Vena Cava Filter Named without a submission number | |
| * | — | Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152765 | Venatech Convertible Vena Cava Filter System | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2007 | Not classified | Z-0264-2008 | Packaging process control | Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152765 (B. Braun Interventional Systems, Inc., 2016) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DTK
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DTK
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTK
432in 2025
MAUDE reports naming product code DTK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 87 | 1 | 364 |
| 2008 | 6 | 87 | 0 | 345 |
| 2009 | 3 | 380 | 0 | 456 |
| 2010 | 3 | 50 | 0 | 369 |
| 2011 | 2 | — | 0 | 439 |
| 2012 | 5 | 156 | 0 | 351 |
| 2013 | 3 | 91 | 1 | 473 |
| 2014 | 2 | — | 0 | 451 |
| 2015 | 2 | — | 1 | 859 |
| 2016 | 3 | 84 | 2 | 2,574 |
| 2017 | 5 | 88 | 0 | 4,364 |
| 2018 | 2 | — | 0 | 3,938 |
| 2019 | 0 | — | 6 | 6,467 |
| 2020 | 0 | — | 0 | 5,405 |
| 2021 | 2 | — | 0 | 5,357 |
| 2022 | 0 | — | 2 | 2,191 |
| 2023 | 0 | — | 0 | 583 |
| 2024 | 5 | 29 | 0 | 406 |
| 2025 | 0 | — | 1 | 432 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VenaTechTM LP Brachial Introducer System (Antecubital) is intended for use with the B. Braun Medical VenaTechTM LP Vena Cava Filter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063217 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063217: Venatech LP Brachial Introducer System (Antecubital).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063217
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026