FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arrow Pressure Injectable Midline Catheter
K Number: K213855
·
Decision Sep 2, 2022
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
12
Applicant Total
1
Review Days
266
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Basic Information
- Device Name
- Arrow Pressure Injectable Midline Catheter
- K Number
- K213855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arrow International, LLC Subsidiary of Teleflex Incorporated
- Date Received
- December 10, 2021
- Decision Date
- September 2, 2022
- Product Code
- PND
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| PND | Midline Catheter | FDA class 2 | General Hospital |
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