HEARTSTRING III PROXIMAL SEAL SYSTEM— 510(k) K080169
Substantially EquivalentGuidant Corporation, Cardiac Surgery
FDA 510(k) clearance K080169 for HEARTSTRING III PROXIMAL SEAL SYSTEM, Substantially Equivalent on 2008-02-08. Applicant: Guidant Corporation, Cardiac Surgery. Device class: 2.
Clearance details
- Applicant
- Guidant Corporation, Cardiac Surgery
- 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
- San Jose, CA, 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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- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
More clearances from Guidant Corporation, Cardiac Surgery
view all- K041340 — GUIDANT MICROWAVE ABLATION SYSTEM
- K023630 — ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
- K024071 — GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
- K023629 — ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
- K022718 — VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.