FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Opticross 35 15 MHz Peripheral Imaging Catheter
K Number: K200733
·
Decision Apr 17, 2020
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
231
Review Days
28
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Basic Information
- Device Name
- Opticross 35 15 MHz Peripheral Imaging Catheter
- K Number
- K200733
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- March 20, 2020
- Decision Date
- April 17, 2020
- Product Code
- ITX
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
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