COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH— 510(k) K032223
Substantially EquivalentCook Vascular, Inc.
FDA 510(k) clearance K032223 for COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH, Substantially Equivalent on 2003-10-15. Applicant: Cook Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook Vascular, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leechburg, PA, US
Recent devices under product code GEI
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- K141148 — EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
- K110347 — DOPPLER MONITOR
- K083482 — COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
- K081425 — COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.