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Edwards Lifesciences Retrograde Cardioplegia Catheter

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
Edwards Lifesciences Retrograde Cardioplegia Catheter FDA UDI
Generic Name
Coronary sinus cannula FDA UDI
Device Name
Retrograde Cardioplegia Catheter FDA UDI
Model / Reference
ISP3071 FDA UDI
Description
Retrograde Cardioplegia Catheter FDA UDI

Identifiers

Catalog Number
ISP3071 FDA UDI
Primary DI / UDI-DI
00690103151374 FDA UDI
510(k) Number
K123187 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

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: Coronary sinus cannula

Edwards Lifesciences Retrograde Cardioplegia Catheter by Edwards Lifesciences LLC — 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

K123187 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 28236bc3-bc3a-499d-aae2-f83b977ab3a9 37 fields · synced Jun 8, 2026