Custom Coronary Manifold Kits
FDA 510(k) K853749 · Procedure Products, Inc.
510(k) numberK853749
Submission
- Device name
- Custom Coronary Manifold Kits
- Applicant
- Procedure Products, Inc.
Vancouver, WA, US - Received
- September 9, 1985
- Decision date
- January 13, 1986
- 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
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| 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 |
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| K922536 | Torque DeviceDQX · Traditional | 12/10/1992SE |
| K914128 | Connecting SetDQO · Traditional | 11/27/1991SE |
| K910673 | Bag SpigotKPE · Traditional | 04/24/1991SE |
| K884985 | Modified 10CC Syringe Control Ring SetFMF · Traditional | 12/20/1988SE |
| K874747 | 10CC Syringe Control Ring SetFMF · Traditional | 02/04/1988SE |
| K874037 | Angio Waste Fluids Dump BagDQO · Traditional | 01/29/1988SE |
| K842173 | Disposable StopcocksFMG · Traditional | 09/05/1984SE |
| K833554 | Material Addition Lexan & K-ResinDQO · Traditional | 03/12/1984SE |
Questions and answers
When was Custom Coronary Manifold Kits cleared by the FDA?
Custom Coronary Manifold Kits (K853749) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 126 days after the submission was received.
What is the product code of K853749?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.