Micro Therapeutics, Inc. d/b/a ev3 Neurovascular: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Micro Therapeutics, Inc. d/b/a ev3 Neurovascular” (first 2014, latest 2025), plus 1 PMA decision, across 10 product codes in 3 review panels. Median 510(k) review time under this name: 100 days. Since 2017 the median was 103 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 106 |
| 2015 | 3 | 62 |
| 2016 | 3 | 75 |
| 2017 | 4 | 113 |
| 2018 | 6 | 105 |
| 2019 | 2 | 166 |
| 2020 | 5 | 29 |
| 2021 | 4 | 120 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 28 |
| 2025 | 1 | 232 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Micro Therapeutics, Inc. d/b/a ev3 Neurovascular took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | 11 | 11 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 6 | 6 |
| DQY | Catheter, Percutaneous | 5 | 5 |
| HCG | Device, Neurovascular Embolization | 4 | 4 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
| OUT | Intracranial Aneurysm Flow Diverter | 1 | 0 |
| QJP | Catheter, Percutaneous, Neurovasculature | 1 | 1 |
Review panels
- Neurology (23)
- Cardiovascular (9)
- General and Plastic Surgery (1)
Most recent Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | QJP | 2025-01-02 | 232 |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing | JCX | 2024-12-02 | 28 |
| K243080 | Riptide Aspiration System | NRY | 2024-10-29 | 29 |
| K211990 | Rist 071 Radial Access Guide Catheter | DQY | 2021-07-27 | 29 |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | HCG | 2021-07-07 | 226 |
| K203358 | Solitaire X Revascularization Device | POL | 2021-03-01 | 105 |
| K202850 | Concerto Versa, Detachable Coil | KRD | 2021-02-09 | 134 |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) | POL | 2020-11-20 | 333 |
| K202318 | Marathon Flow Directed Micro Catheter | KRA | 2020-09-14 | 28 |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | DQX | 2020-07-21 | 29 |
22 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100018 | PMA | PIPELINE EMBOLIZATION DEVICE | 2011-04-06 |
Recalls
openFDA lists no recalls under a recalling firm named Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Micro Media Laboratories (52 510(k)s)
- Micro Therapeutics, Inc. (51 510(k)s)
- Micro Surgical Instruments Corp. (15 510(k)s)
- Micro Motors, Inc. (14 510(k)s)
- Micro Detect, Inc. (11 510(k)s)
- Micro Direct, Inc. (9 510(k)s)
- Micro Current Technology, Inc. (8 510(k)s)
- Micro Audiometrics Corp. (6 510(k)s)
- Micro Tronics Corp. (6 510(k)s)
- Micro Specialties, Inc. (4 510(k)s)
- Micro Dental Laboratories (3 510(k)s)
- Micro Encapsulation Tech. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro Therapeutics, Inc. d/b/a ev3 Neurovascular?
FDA lists 32 510(k) clearances under the applicant name “Micro Therapeutics, Inc. d/b/a ev3 Neurovascular” (first 2014, latest 2025), plus 1 PMA decision, across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro Therapeutics, Inc. d/b/a ev3 Neurovascular is 100 days. Since 2017: 103 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Micro Therapeutics, Inc. d/b/a ev3 Neurovascular?
The most frequent FDA product codes under this applicant name are NRY (Catheter, Thrombus Retriever, 11); POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment, 6); DQY (Catheter, Percutaneous, 5).
Next steps
- See all 32 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular clearances with predicates and recalls
- Run predicate analysis for product code NRY, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.