Manifold Swivel Rotator Models 014320 & 014321-TAB
FDA 510(k) K870073 · Clinical Connections, Inc.
510(k) numberK870073
Submission
- Device name
- Manifold Swivel Rotator Models 014320 & 014321-TAB
- Applicant
- Clinical Connections, Inc.
Orrville, OH, US - Received
- January 8, 1987
- Decision date
- February 20, 1987
- 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 |
|---|---|---|
| K884435 | Resubmitted 1,3 & 4 Way Stopcocks, Various PartsFMG · Traditional | 11/08/1988SE |
| K871540 | Swivel Connectors #014452/#014453/#014459-120FPK · Traditional | 04/30/1987SE |
| K870325 | #014160-TAB Tubing Rotator AdaptorDTL · Traditional | 04/27/1987SE |
| K870477 | Device Connectors #000299-000 3/8 X 3/8 X 3/8 Y · Traditional | 04/03/1987SE |
| K870913 | Injection Site #014456-120FPA · Traditional | 03/17/1987SE |
| K870912 | T-Connectors 014500/014501/014502/014503-120FPK · Traditional | 03/17/1987SE |
| K870324 | #014460-120 3-WAY & #014461-120 4-WAY StopcockFMG · Traditional | 03/13/1987SE |
| K870394 | Hydrophobic #6194418/HYDRAPHILIC #6104418 FiltersFIB · Traditional | 03/03/1987SE |
| K870326 | Various Luer and Tubing FittingsFPK · Traditional | 02/10/1987SE |
Questions and answers
When was Manifold Swivel Rotator Models 014320 & 014321-TAB cleared by the FDA?
Manifold Swivel Rotator Models 014320 & 014321-TAB (K870073) received a 510(k) decision of Substantially Equivalent on February 20, 1987, 43 days after the submission was received.
What is the product code of K870073?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.