FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED HD GUIDE CATHETER
K Number: K080583
·
Decision Jul 18, 2008
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
45
Review Days
137
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Basic Information
- Device Name
- MODIFIED HD GUIDE CATHETER
- K Number
- K080583
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Concentric Medical, Inc.
- Date Received
- March 3, 2008
- Decision Date
- July 18, 2008
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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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 |
| DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm | Sep 2, 2016 | Unknown |
| 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 |