Denver Pleural Effusion Shunt with External Pump Chamber
FDA 510(k) K011020 · Denver Biomedicals, Inc.
510(k) numberK011020
Submission
- Device name
- Denver Pleural Effusion Shunt with External Pump Chamber
- Applicant
- Denver Biomedicals, Inc.
Louisville, CO, US - Received
- April 4, 2001
- Decision date
- June 1, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| 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 |
|---|---|---|
| K051084 | Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage LineDWM · Special | 06/13/2005SE |
| K010642 | Pleurx Pleural Catheter and Drainage KitsDWM · Traditional | 03/20/2001SE |
| K003451 | Denver Pak W/ Double-Valve Ascites Shunt,Denver Pak W/ Single-Valved Ascites Shunt…KPM · Special | 01/02/2001SE |
| K943968 | TunnelerMDM · Traditional | 03/01/1995SE |
| K913728 | Denver(R) Peritoneo-Subclavian ShuntKPM · Traditional | 02/18/1994SE |
| K842139 | The Denver Pleural-Peritoneal ShuntKPM · Traditional | 08/27/1984SE |
| K822686 | Denver Peritoneo-Venous Shunt (Dp-Vs)KPM · Traditional | 09/21/1982SE |
| K811577 | Crouch Corneal ProtectorHOY · Traditional | 08/07/1981SE |
| K811183 | Denver Peritoneo-Venous ShuntKPM · Traditional | 07/01/1981SE |
Questions and answers
When was Denver Pleural Effusion Shunt with External Pump Chamber cleared by the FDA?
Denver Pleural Effusion Shunt with External Pump Chamber (K011020) received a 510(k) decision of Substantially Equivalent on June 1, 2001, 58 days after the submission was received.
What is the product code of K011020?
The FDA product code is KPM – Shunt, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5955.