510(k) · Cleared
ClearedLiisa Lever Integrated Interventional System Adapter, Model VSL-109
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Device Partners International · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Mar 13, 2008 as substantially equivalent to K991102 (Guidant Corp., 1999) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Mar 13, 2008
- Review
- 114 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K854261 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 3 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 2 generations backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- 1 generation backK060759 Y-Click ConnectorElcam Medical Acal · 2006
- This deviceK073260 Liisa Lever Integrated Interventional System Adapter, Model VSL-109Device Partners International · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −3 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −2 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| −1 | K060759 | Y-Click Connector | Elcam Medical Acal | 2006 | — |
| 0 (this device) | K073260 | Liisa Lever Integrated Interventional System Adapter, Model VSL-109 | Device Partners International | 2008 | — |
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 DTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K991102 | Copilot Bleedback Control Valve, Model 1003331Summary page 1…s used to demonstrate substantial equivalence are the CoPilot Bleedback Control Valve marketed by Guidant /Abbott Vascular (K991102) and theY-Click Connector marketed by Elcam Medical (K060759). Device description: The LiiSA Lever Int… | 1999 |
| * | K060759 | Y-Click ConnectorSummary page 1…Bleedback Control Valve marketed by Guidant /Abbott Vascular (K991102) and theY-Click Connector marketed by Elcam Medical (K060759). Device description: The LiiSA Lever Integrated Interventional System AdaptorTM is an Adaptor designe… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 6 other devices also cite its predicate K991102.
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, 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 | 1 | — | 0 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
What is it indicated for?
The LiiSA Lever Integrated Interventional System AdaptorTM is a Y-Connector and hemostasis valve which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic or interventional devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073260: Liisa Lever Integrated Interventional System Adapter, Model VSL-109.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073260
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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