Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath— 510(k) K232037
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K232037 for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath, Substantially Equivalent on 2024-04-04. Applicant: Innovative Health, LLC. Device class: 2.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Product code PNE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Recent devices under product code PNE
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