FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
K Number: K092425
·
Decision Oct 21, 2009
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
29
Applicant Total
21
Review Days
75
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Basic Information
- Device Name
- REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
- K Number
- K092425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ascent Healthcare Solutions
- Date Received
- August 7, 2009
- Decision Date
- October 21, 2009
- Product Code
- OWQ
- 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 |
|---|---|---|---|
| OWQ | Reprocessed Intravascular Ultrasound Catheter | FDA class 2 | Cardiovascular |
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