Reprocessed ViewFlex Xtra ICE Catheter— 510(k) K182238
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K182238 for Reprocessed ViewFlex Xtra ICE Catheter, Substantially Equivalent on 2019-05-08. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
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Recalls naming K182238
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182238.
Data sourced from openFDA. This site is unofficial and independent of the FDA.