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Haart

FDA UDI

Class I (US FDA UDI)

by Corcym Inc.

Identity

Trade Name
HAART FDA UDI
Generic Name
Heart valve annulus sizer, reusable FDA UDI
Device Name
HAART 301 Instrument Set (handles and sizers) FDA UDI
Model / Reference
301-00US FDA UDI
Description
HAART 301 Instrument Set (handles and sizers) FDA UDI

Identifiers

Catalog Number
301-00US FDA UDI
Primary DI / UDI-DI
10857160006314 FDA UDI
510(k) Number
K163608 FDA UDI
FDA Product Code
DTI FDA UDI
GMDN Term
Heart valve annulus sizer, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.3945 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve annulus sizer, reusableHeart valve prosthesis sizer handle

Haart by Corcym Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heart valve prosthesis sizer handle.

Cleared under the same submission

K163608 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corcym Inc.

Sources (1)

  • FDA UDI deebf6ef-cfac-4bd7-a0e9-b2473f114c73 36 fields · synced May 30, 2026