FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K Number: K992631
·
Decision Dec 15, 1999
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
37
Review Days
131
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Basic Information
- Device Name
- ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
- K Number
- K992631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acuson Corp.
- Date Received
- August 6, 1999
- Decision Date
- December 15, 1999
- Product Code
- DQO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- RA
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K023772 | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Nov 22, 2002 | Substantially Equivalent |
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| K021497 | CYPRESS ULTRASOUND SYSTEM | Jul 9, 2002 | Substantially Equivalent |
| K010950 | CYPRESS SYSTEM | Jun 27, 2001 | Substantially Equivalent |
| K002807 | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING | Dec 1, 2000 | Substantially Equivalent |
| K992580 | FETAL ASSESSMENT CAP | Oct 18, 1999 | Substantially Equivalent |
| K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION | Aug 2, 1999 | Substantially Equivalent |
| K973767 | HARMONIC IMAGING WITH CONTRAST | Dec 23, 1997 | Substantially Equivalent |
| K973079 | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM | Nov 5, 1997 | Substantially Equivalent |