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Coronary Perfusion Cannula

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name
Coronary Perfusion Cannula FDA UDI
Generic Name
Vascular irrigation cannula, coronary artery, single-use FDA UDI
Model / Reference
P616-30 FDA UDI

Identifiers

Primary DI / UDI-DI
08033178004169 FDA UDI
510(k) Number
K022280 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Vascular irrigation cannula, coronary artery, single-use 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

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

Category: Vascular irrigation cannula, coronary artery, single-use

Coronary Perfusion Cannula by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular irrigation cannula, coronary artery, single-use.

Cleared under the same submission

K022280 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sorin Group Italia Srl

Sources (1)

  • FDA UDI 26d06e75-8cb7-462c-ade5-77f502defa9b 33 fields · synced May 31, 2026