510(k) · Cleared
ClearedGore-Tex 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 Sep 16, 1981 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Sep 16, 1981
- Review
- 77 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK811841 Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc. · 1981
- Descendant · cites it directly · 9 of its ownK984526 Acuseal Cardiovascular PatchW. L. Gore & Associates, Inc. · 1999
- Descendant · 2 generations on · 6 of its ownK061727 Gore Preclude Vessel GuardW. L. Gore & Associates, Inc. · 2006
- Descendant · 3 generations on · 3 of its ownK082782 Replication Medical Vessel GuardReplication Medical, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK962342 Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996 · Recalled
- Descendant · 2 generations on · 1 of its ownK112683 Smi Cardiovascular PachSolimas Medical, Inc. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K984526Acuseal Cardiovascular PatchW. L. Gore & Associates, Inc. · 1999 · cites it directly9descendants
- K061727Gore Preclude Vessel GuardW. L. Gore & Associates, Inc. · 2006 · 2 generations on6descendants
- K082782Replication Medical Vessel GuardReplication Medical, Inc. · 2009 · 3 generations on3descendants
- K962342Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996 · cites it directly3descendants
- K112683Smi Cardiovascular PachSolimas Medical, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811841 | Gore-Tex Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1981 | — |
| +1 | K984526 | Acuseal Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1999 | — |
| +2 | K061727 | Gore Preclude Vessel Guard | W. L. Gore & Associates, Inc. | 2006 | — |
| +3 | K082782 | Replication Medical Vessel Guard | Replication Medical, Inc. | 2009 | — |
| +1 | K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | 2 |
| +2 | K112683 | Smi Cardiovascular Pach | Solimas Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 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?
- Of its descendants, K984526 (W. L. Gore & Associates, Inc., 1999) has gone furthest, with 9 descendants of its own.
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 | — |
https://510kreport.com/device/K811841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811841: Gore-Tex Cardiovascular Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811841
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026