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Haart

FDA UDI

Class II (US FDA UDI)

by Corcym Inc.

Identity

Trade Name
HAART FDA UDI
Generic Name
Aortic annuloplasty ring FDA UDI
Device Name
Aortic Annuloplasty Device FDA UDI
Model / Reference
200-21US FDA UDI
Description
Aortic Annuloplasty Device FDA UDI

Identifiers

Catalog Number
200-21US FDA UDI
Primary DI / UDI-DI
10857160006246 FDA UDI
510(k) Number
K171431 FDA UDI
FDA Product Code
PST FDA UDI
GMDN Term
Aortic annuloplasty ring FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Aortic annuloplasty ring

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

Similar devices

Also classified as Aortic annuloplasty ring.

Cleared under the same submission

K171431 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 d2d3f268-a50e-4edb-9f65-60fcb19b18a3 36 fields · synced May 30, 2026