CONTINUOUS EPIDURAL ANESTHESIA TRAY— 510(k) K781052
Substantially EquivalentPortex, Inc.
FDA 510(k) clearance K781052 for CONTINUOUS EPIDURAL ANESTHESIA TRAY, Substantially Equivalent on 1978-08-02. Applicant: Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Portex, Inc.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CAZ
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- K031057 — PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
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- K014115 — 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
- K014073 — HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
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.