Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe— 510(k) K152633
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K152633 for Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe, Substantially Equivalent on 2015-10-15. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
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- K241199 — Rotatable Connector (5944RL)
More clearances from Edwards Lifesciences, LLC
view allAdverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.