FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Extroducer Infusion Catheter System
K Number: K213442
·
Decision Jun 10, 2022
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
1
Review Days
228
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Basic Information
- Device Name
- Extroducer Infusion Catheter System
- K Number
- K213442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SmartWise Sweden AB
- Date Received
- October 25, 2021
- Decision Date
- June 10, 2022
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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