Product code NGV ยท Class 3
System, Appendage Closure, Left Atrial
0510(k)s in 12 months (0 all time)
1recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in NGV
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 2 |
| Abbott | 0 | 1 |
| Biosense Webster, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | Abbott Amplatzer Amulet Left Atrial Appendage Occluder
Model Numbers
1. 9-ACP2-007-016
2. 9-ACP2-007-018
3. 9-ACP2-007-020
4. 9-ACP2-007-022
5. 9-ACP2-010-025
6. 9-ACP2-010-028
7. 9-ACP2-010-031
8. 9-ACP2-0 Open, Classified |
NGV | None listed |
| May 7, 2018 | Biosense Webster, Inc. WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523. Terminated |
NGV | None listed |
| Aug 25, 2015 | Boston Scientific Corporation Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). F Terminated |
NGV | None listed |
| Aug 25, 2015 | Boston Scientific Corporation Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12 Terminated |
NGV | None listed |
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