VASOVIEW 5 HARVESTING CANNULA— 510(k) K020143
Substantially EquivalentGuidant Corporation, Cardiac Surgery
FDA 510(k) clearance K020143 for VASOVIEW 5 HARVESTING CANNULA, Substantially Equivalent on 2002-02-20. Applicant: Guidant Corporation, Cardiac Surgery. Device class: 2.
Clearance details
- Applicant
- Guidant Corporation, Cardiac Surgery
- Product code
- Code HET
- Device class
- Class 2
- Regulation
- 21 CFR 884.1720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code HET
view allMore clearances from Guidant Corporation, Cardiac Surgery
view all- K080169 — HEARTSTRING III PROXIMAL SEAL SYSTEM
- 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
Adverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
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.