FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILUMIEN System with AptiVue Software version D.3
K Number: K192267
·
Decision Dec 17, 2019
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
57
Review Days
118
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Basic Information
- Device Name
- ILUMIEN System with AptiVue Software version D.3
- K Number
- K192267
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- August 21, 2019
- Decision Date
- December 17, 2019
- 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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