FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
K Number: K232037
·
Decision Apr 4, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
6
Applicant Total
48
Review Days
269
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Basic Information
- Device Name
- Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- K Number
- K232037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Health, LLC
- Date Received
- July 10, 2023
- Decision Date
- April 4, 2024
- Product Code
- PNE
- 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 |
|---|---|---|---|
| PNE | Reprocessed Catheter Introducer | FDA class 2 | Cardiovascular |
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