Bio-Medicus Tubing Connectors
FDA 510(k) K883956 · Bio Medicus, Inc.
510(k) numberK883956
Submission
- Device name
- Bio-Medicus Tubing Connectors
- Applicant
- Bio Medicus, Inc.
Eden Prairie, MN, US - Received
- September 19, 1988
- Decision date
- October 28, 1988
- 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 |
|---|---|---|
| K920761 | Urine Cultur Stabilization Transport TubeLIO · Traditional | 06/19/1992SE |
| K903410 | Bio-Medicus Cannula IntroducerDYB · Traditional | 10/31/1990SE |
| K901253 | (PBS) Portable Bypass System, Model 1000DTZ · Traditional | 09/05/1990SE |
| K901584 | Bio-Medicus Bio Console Models 540 a B CDWA · Traditional | 06/28/1990SE |
| K894980 | Bio-Cal 370 Heater/CoolerDWJ · Traditional | 11/02/1989SE |
| K884129 | Bio-Medicus Percutaneous Cannula & Introducer SetDQY · Traditional | 12/21/1988SE |
| K872033 | Bio-Medicus Cannula-TubingDWF · Traditional | 12/07/1987SE |
| K861096 | Cardiopulmonary Cannula TubingDWF · Traditional | 05/21/1986SE |
| K854133 | Bio Medicus Bio Console 540DWA · Traditional | 01/08/1986SE |
| K853126 | Bio Pack Model 200DWA · Traditional | 10/11/1985SE |
Questions and answers
When was Bio-Medicus Tubing Connectors cleared by the FDA?
Bio-Medicus Tubing Connectors (K883956) received a 510(k) decision of Substantially Equivalent on October 28, 1988, 39 days after the submission was received.
What is the product code of K883956?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.