AccuVu

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name: AccuVu FDA UDI
Generic Name: Angiographic catheter, single-use FDA UDI
Device Name: AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 2 R/O Markers FDA UDI
Model / Reference: 13709103 FDA UDI
Description: AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 2 R/O Markers FDA UDI

Identifiers

Primary DI / UDI-DI: H787137091030 FDA UDI
510(k) Number: K112452 FDA UDI
K161596 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

Dimensions & Sizes

Size: Outer Diameter — 1.8 Millimeter FDA UDI
Pressure — 1050 Pound per Square Inch FDA UDI
Catheter Gauge — 5 French FDA UDI
Length — 100 Centimeter FDA UDI

Category: Angiographic catheter, single-use

AccuVu by Angiodynamics, Inc — 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

K112452 also covers:

K161596 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Angiodynamics, Inc

Sources (1)

FDA UDI 2e9321ef-98ef-485e-b31e-317f1bee0f95 37 fields · synced Jun 20, 2026