Tempo

FDA UDI

Class II (US FDA UDI)

by Cordis Corp.

Identity

Trade Name: TEMPO FDA UDI
Generic Name: Angiographic catheter, single-use FDA UDI
Device Name: 4 F TEMPO 0.038 125CM H1 FDA UDI
Model / Reference: SRD5449 FDA UDI
Description: 4 F TEMPO 0.038 125CM H1 FDA UDI

Identifiers

Catalog Number: SRD5449 FDA UDI
Primary DI / UDI-DI: 10705032048316 FDA UDI
510(k) Number: K181836 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Angiographic catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 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

FDA UDI

Category: Angiographic catheter, single-use

Tempo by Cordis Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiographic catheter, single-use.

INFINITI — Cordis US Corp. · Class II
Performa® — Merit Medical Systems, Inc. · Class II
Performa® — Merit Medical Systems, Inc. · Class II
Torcon NB — COOK INCORPORATED · Class II
Performa® — Merit Medical Systems, Inc. · Class II
ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
INFINITI — Cordis US Corp. · Class II
CXI — COOK INCORPORATED · Class II

Cleared under the same submission

K181836 also covers:

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: Cordis Corp.

Sources (1)

FDA UDI 6b5c04cf-0b18-4e39-8feb-d0b49ed927b6 35 fields · synced May 30, 2026