510(k) · Cleared
Recalled · 2010Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meadox Medicals, Div. Boston Scientific Corp. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Sep 10, 1996 as substantially equivalent to K955349 (Meadox Medicals, Div. Boston Scientific Corp., 1996) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1981. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 10, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K811841 (1981). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK811841 Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc. · 1981
- This deviceK962342 Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996
- Descendant · cites it directly · 1 of its ownK112683 Smi Cardiovascular PachSolimas Medical, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK122105 Smi Cardiovascular PatchSolinas Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK101740 Albosure Polyester Vascular PatchLeMaitre Vascular, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See allView 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) | K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| +1 | K112683 | Smi Cardiovascular Pach | Solimas Medical, Inc. | 2011 | — |
| +2 | K122105 | Smi Cardiovascular Patch | Solinas Medical, Inc. | 2012 | — |
| +1 | K101740 | Albosure Polyester Vascular Patch | LeMaitre Vascular, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 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 |
|---|---|---|---|
| * | K955349 | Hemashield Knitted Double Velour Cardiovascular FabricSummary page 1…7436 Susan Eichler-Huston Regulatory Affairs Specialist June 14, 1996 HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch HEMASHIELD® Cardiovascular Fabrics (K955349) Gore-Tex® Peripheral Vascular Patch (K821717) Gore-Tex® Cardiovascular Patch (K811841) The HEMASHIELD FINESSE™ Ultra-Thin, Knit… | 1996 |
| * | K821717 | Gore-Tes Expanded Ptfe PatchSummary page 1…Specialist June 14, 1996 HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch HEMASHIELD® Cardiovascular Fabrics (K955349) Gore-Tex® Peripheral Vascular Patch (K821717) Gore-Tex® Cardiovascular Patch (K811841) The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a knitted polyeste… | 1983 |
| * | K811841 | Gore-Tex Cardiovascular PatchSummary page 1…SSE™ Ultra-Thin, Knitted Cardiovascular Patch HEMASHIELD® Cardiovascular Fabrics (K955349) Gore-Tex® Peripheral Vascular Patch (K821717) Gore-Tex® Cardiovascular Patch (K811841) The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a knitted polyester fabric, impregnated with bovine collage… | 1981 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2010 | Not classified | Z-1593-2011 | Other | One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed. |
| May 24, 2010 | Not classified | Z-2064-2010 | Package design/selection | Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K112683 (Solimas Medical, Inc., 2011) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
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/K962342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962342: Hemashield Finesse Ultra-Thin, Knitted 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/K962342
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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