Crosser iQ CTO Recanalization System— 510(k) K203363
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K203363 for Crosser iQ CTO Recanalization System, Substantially Equivalent on 2021-08-12. 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
- Tempe, AZ, 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 →
Recalls naming K203363
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 K203363.
Data sourced from openFDA. This site is unofficial and independent of the FDA.