MTS Catheter Adapter for Guidance Entry
FDA 510(k) K791797 · Medical Testing System, Inc.
510(k) numberK791797
Submission
- Device name
- MTS Catheter Adapter for Guidance Entry
- Applicant
- Medical Testing System, Inc.
Mchenry, IL, US - Received
- September 14, 1979
- Decision date
- October 11, 1979
- 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 |
|---|---|---|
| K801802 | Electromagnetic Blood & Arterial GaugeDPW · Traditional | 01/02/1981SE |
| K801799 | Atrial/Ventricular Seqential #080-20000LDF · Traditional | 01/02/1981SE |
| K801800 | Universal Temp. Pacing Elect. #080-10000LDF · Traditional | 10/23/1980SE |
| K770641 | Mini-Coner TMKNA · Traditional | 06/24/1977SE |
Questions and answers
When was MTS Catheter Adapter for Guidance Entry cleared by the FDA?
MTS Catheter Adapter for Guidance Entry (K791797) received a 510(k) decision of Substantially Equivalent on October 11, 1979, 27 days after the submission was received.
What is the product code of K791797?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.