FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
K Number: K000820
·
Decision Jun 5, 2000
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
15
Review Days
84
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Basic Information
- Device Name
- AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
- K Number
- K000820
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endosonics Corp.
- Date Received
- March 13, 2000
- Decision Date
- June 5, 2000
- 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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|---|---|---|---|
| K990271 | ENDOSONICS TRAK BACK DEVICE | Aug 30, 1999 | Substantially Equivalent |
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| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Aug 6, 1997 | Substantially Equivalent |
| K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | Sep 16, 1996 | Substantially Equivalent |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | Sep 22, 1995 | Substantially Equivalent |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | May 4, 1995 | Substantially Equivalent |
| K926252 | CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY | Oct 25, 1993 | Substantially Equivalent |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | Jan 15, 1993 | Substantially Equivalent |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Jun 25, 1991 | Substantially Equivalent |