INTERLINK THREADED LOCK CANNULA— 510(k) K011858
Substantially EquivalentBd
FDA 510(k) clearance K011858 for INTERLINK THREADED LOCK CANNULA, Substantially Equivalent on 2001-06-19. Applicant: Bd. Device class: 2.
Clearance details
- Applicant
- Bd
- 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
- Special
- Location
- Franklin Lakes, NJ, US
Recent devices under product code FPA
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- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Bd
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- 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 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.