FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
K Number: K090274
·
Decision Mar 3, 2009
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
23
Review Days
27
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Basic Information
- Device Name
- MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
- K Number
- K090274
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micrus Endovascular Corporation
- Date Received
- February 4, 2009
- Decision Date
- March 3, 2009
- 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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Other Clearances by Micrus Endovascular Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO | Jan 26, 2011 | Substantially Equivalent |
| K102818 | MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE | Dec 3, 2010 | Substantially Equivalent |
| K092702 | MICRUS MICROCATHETER, MODEL COURIER 270 | Nov 20, 2009 | Substantially Equivalent |
| K091504 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 | Jun 19, 2009 | Substantially Equivalent |
| K083922 | MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 | May 6, 2009 | Substantially Equivalent |
| K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL | Jan 2, 2009 | Substantially Equivalent |
| K082739 | MICRUS MICROCOIL DELIVERY SYSTEM | Oct 17, 2008 | Substantially Equivalent |
| K080861 | MICRUS ASCENT OCCLUSION BALLOON CATHETER | Aug 27, 2008 | Substantially Equivalent |
| K080379 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT | Jun 30, 2008 | Substantially Equivalent |
| K080437 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF | May 8, 2008 | Substantially Equivalent |