Ave 4F Siteseer Cardiovascular Angiographic Catheter

Q: What is the product code of K984627?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.

FDA 510(k) K984627 · Arterial Vascular Engineering, Inc.

Substantially Equivalent

510(k) numberK984627

Submission

Device name: Ave 4F Siteseer Cardiovascular Angiographic Catheter
Applicant: Arterial Vascular Engineering, Inc.
Billerica, MA, US
Received: December 30, 1998
Decision date: July 27, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DQO – Catheter, Intravascular, Diagnostic
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1200
Specialty: Cardiovascular

Other 510(k)s with product code DQO

510(k)	Device	Applicant	Decision
K261455	Arterial Pressure Monitoring Set/TrayDQO · Traditional	Spectrum Vascular	06/26/2026SE
K252702	Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional	Bioptimal International Pte. , Ltd.	05/28/2026SE
K254278	Arterial Pressure Monitoring Set/TrayDQO · Special	Spectrum Vascular	03/25/2026SE
K250751	DualView CatheterDQO · Traditional	Terumo Corporation	07/17/2025SE
K242966	Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional	Gentuity, LLC	01/31/2025SE
K242420	pNOVUS 21 MicrocatheterDQO · Traditional	Phenox, Ltd.	11/12/2024SE
K233268	Impress Angiographic CatheterDQO · Special	Merit Medical Systems, Inc.	05/22/2024SE
K233975	Zoom 6F Insert CathetersDQO · Traditional	Imperative Care, Inc.	04/02/2024SE
K232536	Soldier MicrocatheterDQO · Traditional	Embolx, Inc.	02/23/2024SE
K232573	INFINITI Ambi Angiographic CatheterDQO · Traditional	Cordis US Corp	11/21/2023SE

More from Cordis US Corp

510(k)	Device	Decision
K983927	GT1 Floppy, GT1 Hi-Per Flex, GT1 Light SupportDQT · Traditional	03/11/1999SE
K971295	Ave Bridge Stent SystemFGE · Traditional	11/05/1997SE

Questions and answers

When was Ave 4F Siteseer Cardiovascular Angiographic Catheter cleared by the FDA?

Ave 4F Siteseer Cardiovascular Angiographic Catheter (K984627) received a 510(k) decision of Substantially Equivalent on July 27, 1999, 209 days after the submission was received.

What is the product code of K984627?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.