CROSSER RECANALIZATION SYSTEM— 510(k) K112308
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K112308 for CROSSER RECANALIZATION SYSTEM, Substantially Equivalent on 2011-08-17. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code PDU
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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Adverse events under product code PDU
product code PDU- Malfunction
- 793
- Total
- 793
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.