Pressure Sensing Syringe 65000
FDA 510(k) K853586 · Dlp, Inc.
510(k) numberK853586
Submission
- Device name
- Pressure Sensing Syringe 65000
- Applicant
- Dlp, Inc.
Grand Rapids, MI, US - Received
- August 26, 1985
- Decision date
- November 14, 1985
- 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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|---|---|---|---|
| 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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| K934215 | Contain-OrKKX · Traditional | 02/09/1994SE |
| K915268 | Catheter Two Stage Venous ReturnDWF · Traditional | 07/27/1992SE |
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| K913077 | Lancaster Cooling Jacket, Cat. Code #13500/13501DTR · Traditional | 01/09/1992SE |
| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501KNW · Traditional | 11/05/1991SE |
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Questions and answers
When was Pressure Sensing Syringe 65000 cleared by the FDA?
Pressure Sensing Syringe 65000 (K853586) received a 510(k) decision of Substantially Equivalent on November 14, 1985, 80 days after the submission was received.
What is the product code of K853586?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.