Mi¯RCSP™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Mi¯RCSP™ FDA UDI
Generic Name: Coronary sinus cannula FDA UDI
Device Name: CANNULA 94533TD MiRCSP 13 AUTO WW 2P 17 FDA UDI
Model / Reference: 94533TD FDA UDI
Description: CANNULA 94533TD MiRCSP 13 AUTO WW 2P 17 FDA UDI

Identifiers

Primary DI / UDI-DI: 20643169086214 FDA UDI
510(k) Number: K090869 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 13.0 French FDA UDI

Category: Coronary sinus cannula

Mi¯RCSP™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary sinus cannula.

Coronary artery cannula — LivaNova USA, Inc. · Class II
PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
Coronary artery cannula — LivaNova USA, Inc. · Class II
Edwards Lifesciences Retrograde Cardioplegia Catheter — Edwards Lifesciences LLC · Class II
Coronary sinus cannula — LivaNova USA, Inc. · Class II
PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
Coronary artery cannula — LivaNova USA, Inc. · Class II

Cleared under the same submission

K090869 also covers:

Mi¯RCSP™ — MEDTRONIC, INC.
Mi¯RCSP™ — MEDTRONIC, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI a28b66db-6cfa-4c3f-b393-348a191197ad 36 fields · synced May 30, 2026