SENSEI X ROBOTIC CATHETER SYSTEM— 510(k) K141822
Substantially EquivalentHanson Medical, Inc.
FDA 510(k) clearance K141822 for SENSEI X ROBOTIC CATHETER SYSTEM, Substantially Equivalent on 2014-08-05. Applicant: Hanson Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Hanson Medical, Inc.
- Product code
- Code DXX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Recent devices under product code DXX
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view allRecalls naming K141822
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 K141822.
Data sourced from openFDA. This site is unofficial and independent of the FDA.