510(k) · Cleared
ClearedAcuseal Cardiovascular Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Apr 8, 1999 as substantially equivalent to K811841 (W. L. Gore & Associates, Inc., 1981) and 2 other predicates after a 108-day review. Its family tree reaches back 1 generation to 1981. 9 later devices descend from it.
- Decided
- Apr 8, 1999
- Review
- 108 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K811841 (1981). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK811841 Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc. · 1981
- This deviceK984526 Acuseal Cardiovascular PatchW. L. Gore & Associates, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK061727 Gore Preclude Vessel GuardW. L. Gore & Associates, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK082782 Replication Medical Vessel GuardReplication Medical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK112683 Smi Cardiovascular PachSolimas Medical, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK103558 Synthes Scout Vessel GuardSynthes Spine · 2011
- Descendant · 2 generations on · 0 of its ownK122105 Smi Cardiovascular PatchSolinas Medical, Inc. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K061727Gore Preclude Vessel GuardW. L. Gore & Associates, Inc. · 2006 · cites it directly6descendants
- K082782Replication Medical Vessel GuardReplication Medical, Inc. · 2009 · 2 generations on3descendants
- K112683Smi Cardiovascular PachSolimas Medical, Inc. · 2011 · cites it directly1descendant
- K103558Synthes Scout Vessel GuardSynthes Spine · 2011 · 2 generations on1descendant
- K122105Smi Cardiovascular PatchSolinas Medical, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811841 | Gore-Tex Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1981 | — |
| 0 (this device) | K984526 | Acuseal Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1999 | — |
| +1 | K061727 | Gore Preclude Vessel Guard | W. L. Gore & Associates, Inc. | 2006 | — |
| +2 | K082782 | Replication Medical Vessel Guard | Replication Medical, Inc. | 2009 | — |
| +1 | K112683 | Smi Cardiovascular Pach | Solimas Medical, Inc. | 2011 | — |
| +2 | K103558 | Synthes Scout Vessel Guard | Synthes Spine | 2011 | — |
| +2 | K122105 | Smi Cardiovascular Patch | Solinas Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 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 DXZ? 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 DXZ device
- #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K811841 | Gore-Tex Cardiovascular PatchSummary page 1…ac patch or pledget made of polyethylene, polyethylene terephthalate, or polytetrafluoroethylene (21 CFR § 870.3470). Device Predicates GORE-TEX® Cardiovascular Patch (K811841 and K912107); CVPro™ Cardiovascular Patch (K943736). Device Description The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovasc… | 1981 |
| * | K912107 | Gore-Tex Expanded Poly. Card. Patch 0.6 and 0.4MMSummary page 1…pledget made of polyethylene, polyethylene terephthalate, or polytetrafluoroethylene (21 CFR § 870.3470). Device Predicates GORE-TEX® Cardiovascular Patch (K811841 and K912107); CVPro™ Cardiovascular Patch (K943736). Device Description The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovascular patch w… | 1991 |
| * | K943736 | Cvpro Cardiovascular PatchSummary page 1…ene terephthalate, or polytetrafluoroethylene (21 CFR § 870.3470). Device Predicates GORE-TEX® Cardiovascular Patch (K811841 and K912107); CVPro™ Cardiovascular Patch (K943736). Device Description The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovascular patch with an optional manufacturing modificat… | 1995 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DXZ devicesDXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXZ
106in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXZ
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DXZ
119in 2025
MAUDE reports naming product code DXZ, 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 | 50 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 109 |
| 2010 | 3 | 91 | 2 | 81 |
| 2011 | 2 | — | 2 | 47 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 1 | — | 2 | 69 |
| 2014 | 3 | 106 | 0 | 93 |
| 2015 | 2 | — | 0 | 171 |
| 2016 | 2 | — | 0 | 66 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 1 | 44 |
| 2019 | 0 | — | 0 | 55 |
| 2020 | 1 | — | 1 | 121 |
| 2021 | 0 | — | 0 | 80 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 2 | 40 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 1 | — | 2 (2) | 119 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ACUSEAL™ Cardiovascular Patch is indicated for use in cardiovascular patching.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984526 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984526: Acuseal Cardiovascular Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984526
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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