AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET— 510(k) K902858
Substantially Equivalent3M Avi, Inc.
FDA 510(k) clearance K902858 for AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET, Substantially Equivalent on 1990-12-14. Applicant: 3M Avi, Inc.. Device class: 2.
Clearance details
- Applicant
- 3M Avi, Inc.
- 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
- Traditional
- Location
- St. Paul, MN, US
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More clearances from 3M Avi, Inc.
view allAdverse 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.