Cps™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: CPS™ FDA UDI
Generic Name: Intravascular catheter slitter FDA UDI
Model / Reference: 4F SLITTER FDA UDI

Identifiers

Catalog Number: DS2A000 FDA UDI
Primary DI / UDI-DI: 05414734508889 FDA UDI
510(k) Number: K082932 FDA UDI
FDA Product Code: DQY FDA UDI
GMDN Term: Intravascular catheter slitter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 4 French FDA UDI

Category: Intravascular catheter slitter

Cps™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular catheter slitter.

ScoutPro Slitter Tool Advanced — BIOTRONIK SE & Co. KG · Class II
Worley™ Slitter — Merit Medical Systems, Inc. · Class I
ACUITY™ — Boston Scientific · Class II
Worley™ Slitter — Merit Medical · Class I
CPS™ — ST. JUDE MEDICAL, INC. · Class II
CPS™ — ST. JUDE MEDICAL, INC. · Class I
CPS 3D Plus — ST. JUDE MEDICAL, INC. · Class I
Agilis HisPro™ — ST. JUDE MEDICAL, INC. · Class I

Cleared under the same submission

K082932 also covers:

CPS AIM™ — ST. JUDE MEDICAL, 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: St. Jude Medical, Inc.

Sources (1)

FDA UDI b039918e-d0a1-4844-9a65-ef9453967b57 37 fields · synced May 30, 2026