Advance Pressure Monitor/High Pressure Lines
FDA 510(k) K911884 · Advance Medical Designs, Inc.
510(k) numberK911884
Submission
- Device name
- Advance Pressure Monitor/High Pressure Lines
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- April 29, 1991
- Decision date
- July 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|
| K223689 | Disposable Needle Guides and GridsITX · Traditional | 08/02/2023SE |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound GelMUI · Traditional | 10/25/2017SE |
| K053495 | Equipment Slush DrapeKKX · Traditional | 03/16/2006SE |
| K011265 | Ultrasound Transducer CoverITX · Traditional | 10/30/2001SE |
| K012168 | Advance Medical Designs Fluid PouchKKX · Traditional | 09/18/2001SE |
| K011422 | Surgical DrapesKKX · Traditional | 07/10/2001SE |
| K003670 | Patient Drape, SurgicalKKX · Traditional | 01/26/2001SE |
| K925115 | Amd Dentist and Hygienist KitsEKJ · Traditional | 07/05/1994SE |
| K915301 | Advance Stopcock/High Pressure StopcockDTL · Traditional | 12/11/1992SE |
| K911732 | Advance Disposable Control SyringeIZI · Traditional | 09/16/1991SE |
Questions and answers
When was Advance Pressure Monitor/High Pressure Lines cleared by the FDA?
Advance Pressure Monitor/High Pressure Lines (K911884) received a 510(k) decision of Substantially Equivalent on July 5, 1994, 1,163 days after the submission was received.
What is the product code of K911884?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.