MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT— 510(k) K012584
Substantially EquivalentBd
FDA 510(k) clearance K012584 for MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT, Substantially Equivalent on 2001-09-06. Applicant: Bd. Device class: 2.
Clearance details
- Applicant
- Bd
- 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
- Special
- Location
- Franklin Lakes, NJ, US
Recent devices under product code CAZ
view allMore clearances from Bd
view all- K253445 — BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
- K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
- K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
- K221504 — BD Surgiphor Antimicrobial Irrigation System
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 →
Recalls naming K012584
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012584.
Data sourced from openFDA. This site is unofficial and independent of the FDA.