EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
FDA 510(k)Class II (US FDA 510(k))
by Abbott
Identifiers
- 510(k) Number
- K183128 FDA 510(k)
- FDA Product Code
- DQK 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)
The EnSite Velocity Cardiac Mapping System v5.2 and EnSite Precision Cardiac Mapping System v2.2 are cardiac mapping systems designed to help healthcare professionals create high-density maps of any chamber of the heart. These systems provide automation, flexibility, and precision to assist in mapping procedures and reduce mapping time.
The systems are used in clinical settings for cardiac electrophysiology procedures. The device data indicates FDA 510K authorization with a substantially equivalent decision, classified under product code DQK for cardiovascular specialty. No specific information on sterility, single-use or reusable status, MRI safety, sizes, or storage is provided in the available data.
Frequently asked questions
What is the primary function of the EnSite Velocity and Precision cardiac mapping systems?
These systems are designed to help healthcare professionals create high-density maps of any chamber of the heart. They provide automation, flexibility, and precision to assist in mapping procedures and reduce the time required for these tasks during clinical cardiac electrophysiology procedures.
Which manufacturer produces the EnSite Velocity v5.2 and Precision v2.2 systems?
The EnSite Velocity Cardiac Mapping System v5.2 and the EnSite Precision Cardiac Mapping System v2.2 are manufactured by Abbott. The company's address is listed as One St. Jude Medical Dr., St. Paul, MN 55117.
What regulatory authorization has been granted to these mapping systems?
The device data indicates that these systems received FDA 510K authorization. The clearance type is listed as Special, with a decision description of Substantially Equivalent, classified under product code DQK for cardiovascular specialty devices.
How do these systems assist in reducing procedure complexity?
The systems are designed to offer automation and flexibility, which helps streamline the mapping process. By providing high-density mapping capabilities for any heart chamber, they aim to enhance precision and efficiency, thereby reducing the overall mapping time required during electrophysiology procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About the EnSite Precision Cardiac Mapping System | Abbott, EnSite Precision Cardiac Mapping System Product Overview | Abbott, EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac ..., EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183128 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA 510(k) K183128 24 fields · synced Sep 28, 2026