Medi-Plast Disposable Manifold

Q: What is the product code of K863402?

The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.

FDA 510(k) K863402 · Medi-Plast Intl., Inc.

Substantially Equivalent

510(k) numberK863402

Submission

Device name: Medi-Plast Disposable Manifold
Applicant: Medi-Plast Intl., Inc.
Atlanta, GA, US
Received: September 3, 1986
Decision date: October 22, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.4290
Specialty: Cardiovascular

Other 510(k)s with product code DTL

510(k)	Device	Applicant	Decision
K152528	Attachable Cath Lab Hemostasis ValveDTL · Traditional	Galt Medical Corp.	12/02/2015SE
K143429	Passage Hemostasis ValveDTL · Special	Merit Medical Systems, Inc.	12/22/2014SE
K140475	Rotating AdaptersDTL · Traditional	Merit Medical Systems, Inc.	04/16/2014SE
K131124	ColignDTL · Traditional	Jilin Coronado Medical , Ltd.	08/28/2013SE
K123448	Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…DTL · Special	Medtronic, Inc.	12/13/2012SE
K122811	Connector Components with Balance BiosurfaceDTL · Special	Medtronic, Inc.	10/12/2012SE
K122301	Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveDTL · Traditional	Vascular Solutions Zerusa , Ltd.	09/07/2012SE
K120069	Medline Stopcock and ManifoldDTL · Traditional	Medline Industries, Inc.	04/03/2012SE
K113148	E-PassDTL · Traditional	Synexmed(Shenzhen)Company Limited	02/28/2012SE
K113845	Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceDTL · Special	Medtronic, Inc.	01/25/2012SE

More from Medtronic, Inc.

510(k)	Device	Decision
K954284	Medi-Plast 2 Port Manifold (Right on)DTL · Traditional	02/12/1996SE
K873588	10CC Control SyringeFMF · Traditional	10/23/1987SE
K861785	Fluoroscope Band BagJAA · Traditional	06/13/1986SE
K851489	Arterial-Venous Compression Dressing · Traditional	06/11/1985SE
K842136	Sterile Pan SetFRG · Traditional	07/06/1984SE
K840021	Operating Room Tray SetFSM · Traditional	03/15/1984SE
K840022	Heart Catheterization Tray SetDRE · Traditional	02/04/1984SE
K811268	Bottle-To-BottleKPE · Traditional	06/18/1981SE
K811234	I.V. Bottle (Ridgid)KPE · Traditional	06/18/1981SE
K811233	I.V. Plastic BagKPE · Traditional	06/17/1981SE

Questions and answers

When was Medi-Plast Disposable Manifold cleared by the FDA?

Medi-Plast Disposable Manifold (K863402) received a 510(k) decision of Substantially Equivalent on October 22, 1986, 49 days after the submission was received.

What is the product code of K863402?

The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.