Steerable catheter control system— 510(k) K183027
Substantially EquivalentStereotaxis, Inc.
FDA 510(k) clearance K183027 for Steerable catheter control system, Substantially Equivalent on 2019-09-06. Applicant: Stereotaxis, Inc.. Device class: 2.
Clearance details
- Applicant
- Stereotaxis, Inc.
- Product code
- Code PJB
- Device class
- Class 2
- Regulation
- 21 CFR 870.5700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code PJB
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