TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool— 510(k) K190884
Substantially EquivalentDatascope Corp.
FDA 510(k) clearance K190884 for TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool, Substantially Equivalent on 2019-12-26. Applicant: Datascope Corp.. Device class: 2.
Clearance details
- Applicant
- Datascope Corp.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, NJ, US
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Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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.