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Cardiac Cryosurgical System

FDA UDI

Class II (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
Cardiac Cryosurgical System FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
ACC2 Cardiac Cryosurgical System FDA UDI
Model / Reference
ACC2 FDA UDI
Description
ACC2 Cardiac Cryosurgical System FDA UDI

Identifiers

Primary DI / UDI-DI
00818354014761 FDA UDI
510(k) Number
K811390 FDA UDI
FDA Product Code
GEH FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4350 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General cryosurgical system, cryogen gas, mechanical

Cardiac Cryosurgical System by Atricure, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, mechanical.

Cleared under the same submission

K811390 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI 6cc03435-7310-4462-9887-cdbedbd1b8f1 36 fields · synced Jun 1, 2026