FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
K Number: K191170
·
Decision Oct 30, 2019
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
68
Applicant Total
40
Review Days
182
Basic Information
- Device Name
- Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
- K Number
- K191170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Health, LLC.
- Date Received
- May 1, 2019
- Decision Date
- October 30, 2019
- Product Code
- NLH
- 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 |
|---|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | FDA class 2 | Cardiovascular |
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