Stopcocks, Manifolds
FDA 510(k) K782095 · Namic
510(k) numberK782095
Submission
- Device name
- Stopcocks, Manifolds
- Applicant
- Namic
Walker, MI, US - Received
- December 18, 1978
- Decision date
- January 23, 1979
- 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 |
|---|---|---|
| K953676 | Breeze Digital Inflation DeviceMAV · Traditional | 03/29/1996SE |
| K951722 | Perceptor Compensator Morse ManifoldDRS · Traditional | 03/25/1996SE |
| K921322 | Morse Anesthesia ManifoldFPA · Traditional | 07/09/1993SE |
| K822100 | High Pressure Contrast Injection LineDQO · Traditional | 08/24/1982SE |
| K813549 | Continuous Flush DeviceDRS · Traditional | 01/12/1982SE |
| K790083 | Catheter, Arterial LineDQY · Traditional | 01/25/1979SE |
| K790082 | Arterial Extension SetDQO · Traditional | 01/25/1979SE |
Questions and answers
When was Stopcocks, Manifolds cleared by the FDA?
Stopcocks, Manifolds (K782095) received a 510(k) decision of Substantially Equivalent on January 23, 1979, 36 days after the submission was received.
What is the product code of K782095?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.