FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
K Number: DEN150049
·
Decision Sep 2, 2016
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
17
Applicant Total
45
Review Days
312
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Basic Information
- Device Name
- Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
- K Number
- DEN150049
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5600
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Concentric Medical, Inc.
- Date Received
- October 26, 2015
- Decision Date
- September 2, 2016
- Product Code
- POL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | FDA class 2 | Neurology |
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Other Clearances by Concentric Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | Feb 15, 2018 | Substantially Equivalent |
| K150616 | Trevo XP ProVue Retriever (4x30mm) | Jun 12, 2015 | Substantially Equivalent |
| K143077 | Trevo XP ProVue Retriever (6X25mm) | Apr 6, 2015 | Substantially Equivalent |
| K133177 | MODIFIED HD GUIDE CATHETER | Feb 25, 2014 | Substantially Equivalent |
| K133464 | MODIFIED TREVO PROVUE RETRIEVER | Jan 17, 2014 | Substantially Equivalent |
| K132641 | MODIFIED TREVO PROVUE RETRIEVER | Jan 13, 2014 | Substantially Equivalent |
| K131437 | MODIFIED CONCENTRIC MICROCATHETER | Oct 11, 2013 | Substantially Equivalent |
| K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER | Oct 3, 2013 | Substantially Equivalent |
| K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 | Nov 21, 2012 | Substantially Equivalent |
| K122478 | MODIFIED TREVO RETRIEVER | Oct 31, 2012 | Substantially Equivalent |