FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K Number: K003084
·
Decision May 16, 2001
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
45
Review Days
225
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Basic Information
- Device Name
- CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
- K Number
- K003084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Concentric Medical, Inc.
- Date Received
- October 3, 2000
- Decision Date
- May 16, 2001
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K150616 | Trevo XP ProVue Retriever (4x30mm) | Jun 12, 2015 | Substantially Equivalent |
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| K133177 | MODIFIED HD GUIDE CATHETER | Feb 25, 2014 | Substantially Equivalent |
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| K131437 | MODIFIED CONCENTRIC MICROCATHETER | Oct 11, 2013 | Substantially Equivalent |
| K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER | Oct 3, 2013 | Substantially Equivalent |
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