SHAPEABLE DOPPLER FLOW PROBE— 510(k) K002958
Substantially EquivalentCook Vascular, Inc.
FDA 510(k) clearance K002958 for SHAPEABLE DOPPLER FLOW PROBE, Substantially Equivalent on 2001-12-18. Applicant: Cook Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook Vascular, Inc.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leechburg, PA, US
Recent devices under product code ITX
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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 ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.