CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2— 510(k) K133916
Substantially EquivalentBiosense Webster, Inc.
FDA 510(k) clearance K133916 for CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2, Substantially Equivalent on 2014-07-01. Applicant: Biosense Webster, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosense Webster, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Diamond Bar, CA, US
Recent devices under product code DQK
view allMore clearances from Biosense Webster, Inc.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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 →
Recalls naming K133916
K-number listed on FDA's recall record- Z-2776-2016 — CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
- Z-0002-2016 — Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133916.
Data sourced from openFDA. This site is unofficial and independent of the FDA.