CONDUCER CARDIOPLEGIA SET SITH MP4— 510(k) K922992
Substantially Equivalent3M Health Care, Ltd.
FDA 510(k) clearance K922992 for CONDUCER CARDIOPLEGIA SET SITH MP4, Substantially Equivalent on 1992-09-18. Applicant: 3M Health Care, Ltd.. Device class: 2.
Clearance details
- Applicant
- 3M Health Care, Ltd.
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DWF
view allMore clearances from 3M Health Care, Ltd.
view allAdverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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 K922992
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 K922992.
Data sourced from openFDA. This site is unofficial and independent of the FDA.