EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upg…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223094

Identifiers

510(k) Number: K223094 FDA 510(k)
FDA Product Code: DQK FDA 510(k)
Models / Variants: EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade FDA 510(k)
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1425 FDA 510(k)
Regulation Number: 870.1425 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upg… by Abbott Medical — Class II — FDA_510K — listed in FDA 510(k) — 2 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K223094	Class II	Active

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Manufacturer

Manufacturer: Abbott Medical

Sources (1)

FDA 510(k) K223094 24 fields · synced Jun 18, 2026