The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Tigerpaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool.
| Device ID | K190884 |
| 510k Number | K190884 |
| Device Name: | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool |
| Classification | Staple, Implantable |
| Applicant | Datascope Corp. 15 Law Drive Fairfield, NJ 07004 |
| Contact | Mark Dinger |
| Correspondent | Mark Dinger Datascope Corp. 15 Law Drive Fairfield, NJ 07004 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-04 |
| Decision Date | 2019-12-26 |
| Summary: | summary |