ADVANSET— 510(k) K771261
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K771261 for ADVANSET, Substantially Equivalent on 1977-08-16. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code DRC
- Device class
- Class 2
- Regulation
- 21 CFR 870.1390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code DRC
product code DRC- Death
- 28
- Injury
- 412
- Total
- 440
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.