FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SubQKath Catheter and Needle Set
K Number: K193664
·
Decision Sep 9, 2020
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
74
Applicant Total
1
Review Days
253
Basic Information
- Device Name
- SubQKath Catheter and Needle Set
- K Number
- K193664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HK Surgical
- Date Received
- December 31, 2019
- Decision Date
- September 9, 2020
- Product Code
- BSO
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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