510(k) K190884
K190884 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool". The FDA issued a decision of Substantially Equivalent on December 26, 2019. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Datascope Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 2019
- Date Received
- April 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type