CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07— 510(k) K994059
Substantially EquivalentHdc Corp.
FDA 510(k) clearance K994059 for CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07, Substantially Equivalent on 2000-10-13. Applicant: Hdc Corp.. Device class: 2.
Clearance details
- Applicant
- Hdc Corp.
- 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
- San Jose, CA, US
Recent devices under product code CAZ
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- K033853 — MODIFICATION TO V-CATH POLY PICC
- K032404 — SELDINGER SAFETY NEEDLE INTRODUCER
- K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
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.