FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRUS COURIER ENZO MICROCATHETER 0.0190
K Number: K072526
·
Decision Oct 5, 2007
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
23
Review Days
28
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Basic Information
- Device Name
- MICRUS COURIER ENZO MICROCATHETER 0.0190
- K Number
- K072526
- 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
- September 7, 2007
- Decision Date
- October 5, 2007
- 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
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
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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