Conphar Manometer Connectors
FDA 510(k) K792113 · Conphar, Inc.
510(k) numberK792113
Submission
- Device name
- Conphar Manometer Connectors
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- October 25, 1979
- Decision date
- December 5, 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 |
|---|---|---|
| K821825 | Conphar Silicone Feeding TubeKNT · Traditional | 08/10/1982SE |
| K821354 | Conphar Mayo Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821295 | Olsen Hegar Needle HoldersGDF · Traditional | 06/03/1982SE |
| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
Questions and answers
When was Conphar Manometer Connectors cleared by the FDA?
Conphar Manometer Connectors (K792113) received a 510(k) decision of Substantially Equivalent on December 5, 1979, 41 days after the submission was received.
What is the product code of K792113?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.