3T L. V. Control Valve
FDA 510(k) K001245 · 3t Medical Systems, LLC
510(k) numberK001245
Submission
- Device name
- 3T L. V. Control Valve
- Applicant
- 3t Medical Systems, LLC
Troy, MI, US - Received
- April 18, 2000
- Decision date
- August 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MJJ – Cpb Check Valve, Retrograde Flow, In-Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
Other 510(k)s with product code MJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182442 | MiniGuard Arterial Safety ValveMJJ · Traditional | Quest Medical, Inc. | 11/06/2018SE |
| K142500 | One Way Soft ValveMJJ · Traditional | Terumo Cardiovascular Systems Corporation | 01/29/2015SE |
| K992785 | Ibc Floguard, Model 6050MJJ · Traditional | International Biophysics Corp. | 01/14/2000SE |
| K982406 | Cobe Vacuum Relief Check ValveMJJ · Abbreviated | Cobe Cardiovascular, Inc. | 10/07/1998SE |
| K960937 | Suction Safety DeviceMJJ · Traditional | R D Intl. | 06/05/1996SE |
| K922781 | Flow Conrol ValveMJJ · Traditional | American Omni Medical, Inc. | 03/08/1993SE |
| K922356 | Flow Control Valve, Cat. No. ACV-38MJJ · Traditional | American Omni Medical, Inc. | 02/12/1993SE |
| K921500 | Centri-Safe(Tm) ValveMJJ · Traditional | Cardio Systems, Inc. | 09/15/1992SE |
More from Cardio Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072697 | 3T Blood Collection Cardiotomy Reservoirs and AccessoriesDTN · Traditional | 12/20/2007SE |
| K022287 | 3T/SEWOON Temperature Sensing Foley CathetersEZL · Traditional | 09/23/2002SE |
| K020768 | 3T Vessel CannulasDWF · Traditional | 08/23/2002SE |
| K020365 | 3TM Myocardial Needle-Temperature ProbeKRI · Traditional | 05/03/2002SE |
Questions and answers
When was 3T L. V. Control Valve cleared by the FDA?
3T L. V. Control Valve (K001245) received a 510(k) decision of Substantially Equivalent on August 15, 2001, 484 days after the submission was received.
What is the product code of K001245?
The FDA product code is MJJ – Cpb Check Valve, Retrograde Flow, In-Line, a Class II (moderate risk) device regulated under 21 CFR 870.4400.