Micro Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Micro Therapeutics, Inc.” (first 1994, latest 2012), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 64 days. 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 |
|---|---|---|
| 2012 | 2 | 182 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | 17 | 17 |
| HCG | Device, Neurovascular Embolization | 11 | 11 |
| MJN | Catheter, Intravascular Occluding, Temporary | 7 | 7 |
| DQX | Wire, Guide, Catheter | 6 | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 4 | 4 |
| KRD | Device, Vascular, For Promoting Embolization | 2 | 2 |
| MCW | Catheter, Peripheral, Atherectomy | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
Review panels
- Cardiovascular (35)
- Neurology (11)
- General Hospital (5)
Most recent Micro Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113289 | ORION MICRO CATHETER | KRA | 2012-08-01 | 268 |
| K113454 | 14 WIRE STANDARD, 14 WIRE LS | DQX | 2012-02-24 | 95 |
| K090870 | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY | KRA | 2009-05-01 | 32 |
| K090046 | CONCERTO DETACHABLE COIL SYSTEM | KRD | 2009-02-27 | 51 |
| K081465 | AXIUM DETACHABLE COIL SYSTEM | KRD | 2008-08-19 | 84 |
| K060747 | FX DETACHABLE COIL SYSTEM | HCG | 2007-04-24 | 400 |
| K060625 | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR | HCG | 2006-04-20 | 42 |
| K051990 | ECHELON MICRO CATHETER | KRA | 2006-01-04 | 166 |
| K051560 | NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR | HCG | 2005-06-28 | 15 |
| K051425 | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR | HCG | 2005-06-22 | 21 |
41 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 6 recall events; 9 initiated in the last five years. Most recent: 2026-06-08.
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. d/b/a ev3 Neurovascular (32 510(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.?
FDA lists 51 510(k) clearances under the applicant name “Micro Therapeutics, Inc.” (first 1994, latest 2012), across 9 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.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro Therapeutics, Inc. is 64 days.
Which FDA product codes appear under Micro Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are KRA (Catheter, Continuous Flush, 17); HCG (Device, Neurovascular Embolization, 11); MJN (Catheter, Intravascular Occluding, Temporary, 7).
Next steps
- See all 51 Micro Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KRA, Micro Therapeutics, Inc.'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.