V-Cath Picc (Peripherally Inserted Central Catheter) See Appendix 1

Q: What is the product code of K983409?

The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.

FDA 510(k) K983409 · Hdc Corp.

Substantially Equivalent

510(k) numberK983409

Submission

Device name: V-Cath Picc (Peripherally Inserted Central Catheter) See Appendix 1
Applicant: Hdc Corp.
San Jose, CA, US
Received: September 28, 1998
Decision date: October 16, 1998
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5200
Specialty: General Hospital

Other 510(k)s with product code FOZ

510(k)	Device	Applicant	Decision
K260432	Ruby Intravascular CatheterFOZ · Traditional	Venocare, Inc.	09/02/2026SE
K260165	Unimpregnated Central Venous CatheterFOZ · Traditional	Spectrum Vascular	08/10/2026SE
K261041	ClearSafe Closed SystemFOZ · Traditional	MedSource Labs, LLC	07/10/2026SE
K260539	MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional	MedSource Labs, LLC	07/09/2026SE
K253235	Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional	B.Braun Medical, Inc.	05/15/2026SE
K252137	BD Insyte IV CatheterFOZ · Traditional	Becton Dickinson Infusion Therapy Systems, Inc.	04/02/2026SE
K252513	Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special	Poly Medicure Limited	04/01/2026SE
K252398	SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional	Terumo Medical Products (Hangzhou) Co., Ltd.	12/17/2025SE
K252677	Polyshield Safety IV CathetersFOZ · Special	Poly Medicure Limited	11/05/2025SE
K251422	BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional	Becton Dickinson Infusion Therapy Systems, Inc.	10/08/2025SE

More from Becton Dickinson Infusion Therapy Systems, Inc.

510(k)	Device	Decision
K071875	V-Cath Poly PiccLJS · Traditional	11/05/2007SE
K023342	Neuro-Trace III Kit, Neuro-Trace III Regional Block Cable, Neuro-Trace III Nerve Mapping…KOI · Traditional	03/02/2004SE
K033853	Modification to V-Cath Poly PiccFOZ · Special	01/14/2004SE
K032404	Seldinger Safety Needle IntroducerDYB · Special	09/10/2003SE
K022752	Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15…CAZ · Traditional	09/09/2003SE
K022099	Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SFOZ · Traditional	09/20/2002SE
K010425	Epidural Catheter with Connector (and Accessory)KNF · Special	03/15/2001SE
K994059	Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07CAZ · Traditional	10/13/2000SE
K002770	Ibis Chemo-Port Implantable Vascular Access System, Model…LJT · Special	09/26/2000SE
K983119	Entero-Test HP, Model #102-01LIO · Traditional	03/15/1999SE

Questions and answers

When was V-Cath Picc (Peripherally Inserted Central Catheter) See Appendix 1 cleared by the FDA?

V-Cath Picc (Peripherally Inserted Central Catheter) See Appendix 1 (K983409) received a 510(k) decision of Substantially Equivalent on October 16, 1998, 18 days after the submission was received.

What is the product code of K983409?

The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.