Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber
FDA 510(k) K012235 · Denver Biomedical, Inc.
510(k) numberK012235
Submission
- Device name
- Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber
- Applicant
- Denver Biomedical, Inc.
Golden, CO, US - Received
- July 17, 2001
- Decision date
- October 4, 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 |
| 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 |
|---|---|---|
| K051711 | Pleurx Peritoneal Catheter Kit and Pleurx Drainage KitsPNG · Traditional | 11/15/2005SE |
| K052436 | Pleurx Pleural Catheter Kit, Model 50-7000DWM · Special | 10/06/2005SE |
| K011862 | Denver Ascites Shunt and Percutaneous Access Kit with Ascities ShuntKPM · Special | 07/12/2001SE |
| K011831 | Modification to Pleurx Pleural Catheter and Drainage KitsDWM · Special | 06/28/2001SE |
Questions and answers
When was Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber cleared by the FDA?
Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber (K012235) received a 510(k) decision of Substantially Equivalent on October 4, 2001, 79 days after the submission was received.
What is the product code of K012235?
The FDA product code is KPM – Shunt, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5955.