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Gundry®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Gundry® FDA UDI
Generic Name
Coronary sinus cannula FDA UDI
Device Name
CANNULA 94715 RCSP 15F SIL-MAN 10PK 17L FDA UDI
Model / Reference
94715 FDA UDI
Description
CANNULA 94715 RCSP 15F SIL-MAN 10PK 17L FDA UDI

Identifiers

Primary DI / UDI-DI
20643169454716 FDA UDI
510(k) Number
K860149 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Coronary sinus cannula FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Dimensions & Sizes

Size
Catheter Gauge — 15.0 French FDA UDI

Category: Coronary sinus cannula

Gundry® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary sinus cannula.

Cleared under the same submission

K860149 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 5cbb8a7e-05fe-4e05-b431-74f89a10002b 36 fields · synced May 31, 2026