Manifold

Q: When was Manifold cleared by the FDA?

Manifold (K972654) received a 510(k) decision of Substantially Equivalent on October 8, 1997, 85 days after the submission was received.

Q: What is the product code of K972654?

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) K972654 · Medical Specialties Intl., Inc.

Substantially Equivalent

510(k) numberK972654

Submission

Device name: Manifold
Applicant: Medical Specialties Intl., Inc.
Tarpon Springs, FL, US
Received: July 15, 1997
Decision date: October 8, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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
K972655	Control SyringeIZI · Traditional	11/04/1997SE
K952385	Hema-Trol Q-CheckJJY · Traditional	09/25/1995SE
K940430	SedratrolGJR · Traditional	02/06/1995SE
K895373	Hematology ControlJCN · Traditional	10/06/1989SE

Questions and answers

When was Manifold cleared by the FDA?

Manifold (K972654) received a 510(k) decision of Substantially Equivalent on October 8, 1997, 85 days after the submission was received.

What is the product code of K972654?

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