REPROCESSED ELECTROPHYSIOLOGY CATHETERS— 510(k) K112232
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K112232 for REPROCESSED ELECTROPHYSIOLOGY CATHETERS, Substantially Equivalent on 2011-09-26. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- 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
- Tempe, AZ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.