COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET— 510(k) K083482
Substantially EquivalentCook Vascular, Inc.
FDA 510(k) clearance K083482 for COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET, Substantially Equivalent on 2009-04-02. Applicant: Cook Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook Vascular, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vandergrift, PA, US
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More clearances from Cook Vascular, Inc.
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- K141148 — EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
- K110347 — DOPPLER MONITOR
- K081425 — COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
- K061000 — EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.