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510(k) Data Aggregation
K Number
K102588Device Name
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
Manufacturer
MEDTRONIC ABLATION FRONTIERS, LLC
Date Cleared
2011-03-18
(190 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC ABLATION FRONTIERS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Catheter is designed to obtain electrograms in the atrial regions of the heart.
Device Description
The Achieve™ diagnostic mapping catheter is an intra-cardiac electrophysiology recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the Achieve catheter is a circular loop with eight evenly spaced electrodes to map electrical conduction within the atrium. The Achieve catheter should only be used with the corresponding electrical cable for Achieve. The Achieve catheter is available with two distal loop diameter sizes described in the following table:
| Model | Loop Diameter |
|------------|---------------|
| 990063-015 | 15 mm |
| 990063-020 | 20 mm |
The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment.
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