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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port FDA UDI
Model / Reference
IPN000188 FDA UDI
Description
Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port FDA UDI

Identifiers

Catalog Number
CP-08803 FDA UDI
Primary DI / UDI-DI
00801902001603 FDA UDI
510(k) Number
K780532 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

Yes

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

Dimensions & Sizes

Size
Width — 11 Centimeter FDA UDI
Catheter Gauge — 8 French FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Cleared under the same submission

K780532 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 8e101e7e-b3c4-46a8-8e72-6730e4776978 37 fields · synced Jun 8, 2026