Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters— 510(k) K211276
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K211276 for Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters, Substantially Equivalent on 2021-09-15. Applicant: Innovative Health, LLC. Device class: 2.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Code NLH
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Recent devices under product code NLH
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- K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
- K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
More clearances from Innovative Health, LLC
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- K213584 — Reprocessed NRG Transseptal Needle
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Data sourced from openFDA. This site is unofficial and independent of the FDA.