K190884 is an FDA 510(k) clearance for the TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on December 26, 2019, 266 days after receiving the submission on April 4, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K190884 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2019 |
| Decision Date | December 26, 2019 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4750 |