ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200— 510(k) K023629
Substantially EquivalentGuidant Corporation, Cardiac Surgery
FDA 510(k) clearance K023629 for ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200, Substantially Equivalent on 2002-11-12. Applicant: Guidant Corporation, Cardiac Surgery. Device class: 2.
Clearance details
- Applicant
- Guidant Corporation, Cardiac Surgery
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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More clearances from Guidant Corporation, Cardiac Surgery
view all- K080169 — HEARTSTRING III PROXIMAL SEAL SYSTEM
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- K024071 — GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
- K022718 — VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.