Cardiovascular · 510(k) · 2023
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc.. Cleared by FDA on 7 September 2023 under submission K231207, product code DQK (computer, diagnostic, programmable). What FDA's record says, in FDA's words.
Device record · K231207
- Device. CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DEVICE
- Company. Biosense Webster, Inc.COMPANY
- Decision. 7 September 2023, 510(k), substantially equivalent (traditional review); received 27 April 2023DECISION
- Panel. CardiovascularPANEL
- Product code. DQK, Computer, Diagnostic, ProgrammableCODE
- Regulation. 21 CFR 870.1425, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTOTM 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,558 reports filed against devices carrying product code DQK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · QUANTIEN · Abbott Medical · report 2184149-2026-00257
During a fractional flow reserve procedure with QUANTIEN, it was noted that the PA signals were not appearing on the monitor leading to the procedure being cancelled. There were no adverse patient consequences.
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18928
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18932
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18933
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18934
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DQK, in Cardiovascular, from Biosense Webster, Inc., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.