Denver Peritoneo-Venous Shunt (DP-VS)
510(k) K822686
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822686 | Date21 Sep 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPM
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5955
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Denver Peritoneo-Venous Shunt (DP-VS) is a peritoneal shunt device designed to transfer fluid from the peritoneal cavity to the venous system. It is classified as a Class II medical device and is intended for use in gastroenterology and urology procedures.
The device is supplied by Denver Biomedicals, Inc. and received FDA 510(k) clearance with number K822686 on September 21, 1982. It is regulated under product code KPM and regulation number 876.5955. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Other devices from Denver Biomedicals, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Denver Peritoneo-Venous Shunt used for?
The Denver Peritoneo-Venous Shunt (DP-VS) is designed to transfer fluid from the peritoneal cavity to the venous system, primarily used in gastroenterology and urology procedures.
Is the Denver Peritoneo-Venous Shunt single-use or reusable?
The device is not specified as single-use or reusable in the provided information, so clinicians should refer to the manufacturer's instructions for specific guidance on reuse.
What regulatory approvals does the Denver Peritoneo-Venous Shunt have?
The Denver Peritoneo-Venous Shunt received FDA 510(k) clearance with number K822686 on September 21, 1982, and is classified as a Class II medical device under product code KPM.
What are the specifications of the Denver Peritoneo-Venous Shunt?
The Denver Peritoneo-Venous Shunt is manufactured by Denver Biomedicals, Inc. and is designed for peritoneal fluid transfer to the venous system, with no specific size or model details provided in the data.