HEARTSTRING III PROXIMAL SEAL SYSTEM— 510(k) K130382
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K130382 for HEARTSTRING III PROXIMAL SEAL SYSTEM, Substantially Equivalent on 2013-06-05. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, NJ, US
Recent devices under product code DXC
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- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K252772 — Arc Adjustable Radial Cuff Compression Device
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More clearances from Boston Scientific Corporation
view allAdverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K130382
K-number listed on FDA's recall record- Z-2586-2025 — Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
- Z-2587-2025 — Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
- Z-2588-2025 — Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130382.
Data sourced from openFDA. This site is unofficial and independent of the FDA.