Vygon Stopcocks & Ramps(Manifolds)
FDA 510(k) K813141 · Exco, Inc.
510(k) numberK813141
Submission
- Device name
- Vygon Stopcocks & Ramps(Manifolds)
- Applicant
- Exco, Inc.
Mchenry, IL, US - Received
- November 5, 1981
- Decision date
- November 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K844203 | Enternal Feeding Tube SILICONE-EF401, 402 & 403KNT · Traditional | 01/02/1985SE |
| K844175 | Enternal Feeding Tube-Polyurethane EF504KNT · Traditional | 01/02/1985SE |
| K844174 | Flexible Stainless Steel Stylet for Enternal FeediKNT · Traditional | 12/07/1984SE |
| K832628 | Vygon Thoracic Drainage-Various #'SKDD · Traditional | 01/30/1984SE |
| K831802 | Life Vac #2191 & 2192LJS · Traditional | 01/11/1984SE |
| K833079 | Centracath #130,135 & 137-HEMOCATH #FOZ · Traditional | 12/29/1983SE |
| K830910 | Manometer Set C.V.P. #S 298/299KRK · Traditional | 04/05/1983SE |
| K822879 | Enteral Nutrition 1KNT · Traditional | 11/16/1982SE |
| K822836 | Microflex-VenofluxFPA · Traditional | 10/15/1982SE |
| K822691 | Vygon Epidural Anaesthesia TrayCAZ · Traditional | 10/15/1982SE |
Questions and answers
When was Vygon Stopcocks & Ramps(Manifolds) cleared by the FDA?
Vygon Stopcocks & Ramps(Manifolds) (K813141) received a 510(k) decision of Substantially Equivalent on November 27, 1981, 22 days after the submission was received.
What is the product code of K813141?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.