DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE— 510(k) K863482
Substantially EquivalentCardio Metrics, Inc.
FDA 510(k) clearance K863482 for DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE, Substantially Equivalent on 1986-10-14. Applicant: Cardio Metrics, Inc.. Device class: 1.
Clearance details
- Applicant
- Cardio Metrics, Inc.
- Product code
- Code GCY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4680
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code GCY
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- K965140 — CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
- K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE
- K961777 — ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
- K955551 — CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404
Adverse events under product code GCY
product code GCY- Malfunction
- 786
- Other
- 1
- Total
- 787
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.