REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER— 510(k) K110076
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K110076 for REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER, Substantially Equivalent on 2011-08-18. Applicant: Sterilmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilmed, Inc.
- 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
- Maple Grove, MN, US
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Recalls naming K110076
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 K110076.
Data sourced from openFDA. This site is unofficial and independent of the FDA.