Leveen Peritineo-Venous Shunt
FDA 510(k) K901360 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK901360
Submission
- Device name
- Leveen Peritineo-Venous Shunt
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- March 23, 1990
- Decision date
- August 21, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPM – Shunt, Peritoneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5955
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code KPM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES SystemKPM · Traditional | Pleural Dynamics, Inc. | 08/18/2023SE |
| K170405 | BD Curve Ascites ShuntKPM · Traditional | Care Fusion | 11/02/2017SESK |
| K012235 | Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump ChamberKPM · Special | Denver Biomedical, Inc. | 10/04/2001SE |
| K011862 | Denver Ascites Shunt and Percutaneous Access Kit with Ascities ShuntKPM · Special | Denver Biomedical, Inc. | 07/12/2001SE |
| K011020 | Denver Pleural Effusion Shunt with External Pump ChamberKPM · Special | Denver Biomedicals, Inc. | 06/01/2001SE |
| K003451 | Denver Pak W/ Double-Valve Ascites Shunt,Denver Pak W/ Single-Valved Ascites Shunt…KPM · Special | Denver Biomedicals, Inc. | 01/02/2001SE |
| K973129 | Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access KitsKPM · Traditional | Denver Biomaterials, Inc. | 03/17/1998SE |
| K962814 | Denver Pleural Effusion Shunt with External Pump ChamberKPM · Traditional | Denver Biomaterials, Inc. | 04/14/1997SE |
| K913728 | Denver(R) Peritoneo-Subclavian ShuntKPM · Traditional | Denver Biomedicals, Inc. | 02/18/1994SE |
| K894794 | Agishi Ascites Pump Peritoneocaval Shunt PumpKPM · Traditional | Vitaid, Ltd. | 11/21/1989SE |
More from Vitaid, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Leveen Peritineo-Venous Shunt cleared by the FDA?
Leveen Peritineo-Venous Shunt (K901360) received a 510(k) decision of Substantially Equivalent on August 21, 1990, 151 days after the submission was received.
What is the product code of K901360?
The FDA product code is KPM – Shunt, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5955.