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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
CATH TEMPO 4F SHK 1.0 65CM FDA UDI
Model / Reference
451450V0J FDA UDI
Description
CATH TEMPO 4F SHK 1.0 65CM FDA UDI

Identifiers

Catalog Number
451450V0J FDA UDI
Primary DI / UDI-DI
10705032008136 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

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: 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.

Cleared under the same submission

K181836 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cordis Corp.

Sources (1)

  • FDA UDI b2be57d7-9d64-42ee-9a38-9b379e63c556 35 fields · synced May 30, 2026