Denver Peritoneo-Venus Shunt
FDA 510(k) K894756 · Codman & Shurtleff, Inc.
510(k) numberK894756
Submission
- Device name
- Denver Peritoneo-Venus Shunt
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- July 27, 1989
- Decision date
- September 29, 1989
- 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 |
| K901360 | Leveen Peritineo-Venous ShuntKPM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/21/1990SE |
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| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
Questions and answers
When was Denver Peritoneo-Venus Shunt cleared by the FDA?
Denver Peritoneo-Venus Shunt (K894756) received a 510(k) decision of Substantially Equivalent on September 29, 1989, 64 days after the submission was received.
What is the product code of K894756?
The FDA product code is KPM – Shunt, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5955.