Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Regulation 882.5600
0510(k)s in 12 months (18 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in POL
| Company | 510(k)s | Recalls |
|---|---|---|
| Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 6 | 0 |
| Stryker Neurovascular | 3 | 3 |
| Phenox Limited | 3 | 0 |
| Stryker | 3 | 0 |
| Concentric Medical, Inc. | 2 | 0 |
| Medtronic Neurovascular | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | Stryker Neurovascular Trevo NXT ProVue 3 x 32, US, Catalog: 90312
Kits:
TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412
TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413
TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 Open, Classified |
POL | K223305 |
| May 28, 2024 | Stryker Neurovascular Trevo XP ProVue Retriever 4 x 20, Catalog: 90182
Trevo XP ProVue Retriever 3 x 20, Catalog: 90183
Trevo XP ProVue Retriever 4 x 30, Catalog: 90185
Trevo XP ProVue Retriever 6 x 25, Catalog: 90186
Kit Open, Classified |
POL | K173352 |
| Oct 21, 2020 | Stryker Neurovascular Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK6 Terminated |
POL | K190779 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.