ETHICON TEMPORARY CARDIAC PACING WIRE— 510(k) K822155
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K822155 for ETHICON TEMPORARY CARDIAC PACING WIRE, Substantially Equivalent on 1982-08-24. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code LOF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5870
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code LOF
product code LOF- Death
- 3
- Injury
- 1,058
- Total
- 1,061
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.