BD Curve Ascites Shunt
FDA 510(k) K170405 · Care Fusion
510(k) numberK170405
Submission
- Device name
- BD Curve Ascites Shunt
- Applicant
- Care Fusion
Vernon Hills, IL, US - Received
- February 10, 2017
- Decision date
- November 2, 2017
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K901360 | Leveen Peritineo-Venous ShuntKPM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/21/1990SE |
| K894794 | Agishi Ascites Pump Peritoneocaval Shunt PumpKPM · Traditional | Vitaid, Ltd. | 11/21/1989SE |
More from Vitaid, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access DeviceLHI · Traditional | 03/06/2024SE |
| K231888 | BD Texium Needle-Free SyringeFMF · Traditional | 09/25/2023SE |
| K221327 | BD Alaris Pump Infusion SetsFPA · Traditional | 07/21/2023SE |
| K221319 | BD Alaris Pump Epidural Infusion SetPWH · Traditional | 07/21/2023SE |
| K223101 | BD Secondary Infusion SetFPA · Traditional | 05/12/2023SE |
| K223088 | BD SmartSite Needle-Free ConnectorFPA · Traditional | 04/07/2023SE |
| K223076 | BD Texium Closed Male LuerONB · Traditional | 03/24/2023SE |
| K201155 | PleurX Peritoneal Catheter SystemPNG · Traditional | 10/21/2020SESK |
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…KNW · Traditional | 09/11/2017SE |
| K153748 | AirLife Misty Finity NebulizerCAF · Traditional | 05/17/2017SE |
Questions and answers
When was BD Curve Ascites Shunt cleared by the FDA?
BD Curve Ascites Shunt (K170405) received a 510(k) decision of Unknown on November 2, 2017, 265 days after the submission was received.
What is the product code of K170405?
The FDA product code is KPM – Shunt, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5955.