Product code OUT ยท Class 3
Intracranial Aneurysm Flow Diverter
0510(k)s in 12 months (0 all time)
3recalls in 12 months (14 all time)
0recalls that name a 510(k)
Top companies in OUT
| Company | 510(k)s | Recalls |
|---|---|---|
| Micro Therapeutics Inc, | 0 | 7 |
| Micro Therapeutics Inc, Dba Ev3 Neurovascular | 0 | 5 |
| MICROVENTION INC. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2026 | Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12
UDI-DI code: 00763000448806
he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combin Open, Classified |
OUT | None listed |
| Jul 22, 2026 | Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027
REF PED2-300-20. Intracranial aneurysm flow diverter Open, Classified |
OUT | None listed |
| Jul 22, 2026 | Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027
REF PED2-300-12. Intracranial aneurysm flow diverter Open, Classified |
OUT | None listed |
| Oct 10, 2025 | MICROVENTION INC. Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827;
FRED X 27, REF: XFRED401 Open, Classified |
OUT | None listed |
| Mar 5, 2025 | Micro Therapeutics, Inc. Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3- Open, Classified |
OUT | None listed |
| Mar 5, 2025 | Micro Therapeutics, Inc. Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3- Open, Classified |
OUT | None listed |
| Jul 27, 2023 | MICROVENTION INC. FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012- Open, Classified |
OUT | None listed |
| Jul 13, 2021 | Micro Therapeutics Inc, EV3 Pipeline Flex Embolization Device with Flex Shield Technology Open, Classified |
OUT | None listed |
| Jul 13, 2021 | Micro Therapeutics Inc, Pipeline Flex Embolization Device Open, Classified |
OUT | None listed |
| Mar 9, 2020 | Micro Therapeutics Inc, Dba Ev3 Neurovascular ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use. Terminated |
OUT | None listed |
| Mar 9, 2020 | Micro Therapeutics Inc, Dba Ev3 Neurovascular ev3 Pipeline Flex Embolization Device. For neurological endovascular use. Terminated |
OUT | None listed |
| Nov 9, 2016 | Micro Therapeutics Inc, Dba Ev3 Neurovascular Pipeline Embolization Device (Pipeline Classic)
The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) i Terminated |
OUT | None listed |
| Oct 14, 2015 | Micro Therapeutics Inc, Dba Ev3 Neurovascular -Pipeline Embolization Device
-Pipeline Flex Embolization Device
The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. T Terminated |
OUT | None listed |
| Aug 23, 2013 | Micro Therapeutics Inc, Dba Ev3 Neurovascular Pipeline Embolization Device (PED)
The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneu Terminated |
OUT | None listed |
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