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EnSite™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
EnSite™ FDA UDI
Generic Name
Cardiac mapping system application software FDA UDI
Device Name
Catheter Catalog Installation FDA UDI
Model / Reference
H700293 FDA UDI
Description
Catheter Catalog Installation FDA UDI

Identifiers

Catalog Number
H700293 FDA UDI
Primary DI / UDI-DI
05415067002938 FDA UDI
510(k) Number
K141050 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac mapping system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac mapping system application software

EnSite™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system application software.

Cleared under the same submission

K141050 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI f44011f4-f1f9-4eaf-b4e7-5ad4a808911a 37 fields · synced May 29, 2026