FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
K Number: K083922
·
Decision May 6, 2009
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
23
Review Days
126
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Basic Information
- Device Name
- MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
- K Number
- K083922
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micrus Endovascular Corporation
- Date Received
- December 31, 2008
- Decision Date
- May 6, 2009
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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|---|---|---|---|
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| 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 |