FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Park Blade Septostomy Catheter
K Number: K182399
·
Decision Apr 4, 2019
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
19
Applicant Total
175
Review Days
212
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Basic Information
- Device Name
- Park Blade Septostomy Catheter
- K Number
- K182399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5175
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- September 4, 2018
- Decision Date
- April 4, 2019
- Product Code
- DXF
- 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 |
|---|---|---|---|
| DXF | Catheter, Septostomy | FDA class 2 | Cardiovascular |
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