PMA · Approved
Recalled · Class II · 2012Cordis Exoseal Vascular Closure Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis US Corporation · MGB Device, Hemostasis, Vascular
Approved on May 19, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 413-day review. It has been recalled once.
- Decided
- May 19, 2011
- Review
- 413 days
- Class
- Class III
- Product code
- MGB
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100013 has 32 supplements since 2011: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2011 | 2 |
| 2012 | 6 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 3 |
| 2025 | 3 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MGB? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2012 | Class II | Z-0740-2013 | Material/Component Contamination | Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MGB devicesMGB Device, Hemostasis, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MGB
18in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MGB
Too few MGB 510(k)s in any year since 2007 to give a median.
Recalls per year · MGB
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGB
12,664in 2025
MAUDE reports naming product code MGB, 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 | 18 | — | 0 | 1,588 |
| 2008 | 20 | — | 0 | 2,267 |
| 2009 | 34 | — | 1 | 2,436 |
| 2010 | 22 | — | 0 | 3,933 |
| 2011 | 23 | — | 0 | 4,011 |
| 2012 | 16 | — | 1 | 3,786 |
| 2013 | 12 | — | 0 | 3,011 |
| 2014 | 26 | — | 0 | 4,468 |
| 2015 | 28 | — | 0 | 3,944 |
| 2016 | 26 | — | 0 | 4,330 |
| 2017 | 15 | — | 0 | 5,346 |
| 2018 | 23 | — | 0 | 5,679 |
| 2019 | 27 | — | 0 | 6,156 |
| 2020 | 10 | — | 0 | 5,927 |
| 2021 | 17 | — | 0 | 7,586 |
| 2022 | 11 | — | 0 | 9,457 |
| 2023 | 18 | — | 2 | 13,529 |
| 2024 | 22 | — | 0 | 13,762 |
| 2025 | 18 | — | 0 | 12,664 |
| 2026 | 24 | — | 0 | — |
https://510kreport.com/device/P100013 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100013: Cordis Exoseal Vascular Closure Device.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100013
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026