Skip to content

Denver Pleural-Peritoneal Shunt

by Denver Biomedicals, Inc.

510(k) K842139

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842139 Date27 Aug 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
The Denver Pleural-Peritoneal Shunt
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, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Denver Pleural-Peritoneal Shunt is a peritoneal shunt device designed for the management of fluid accumulation. It functions by facilitating the drainage of fluid from the pleural space into the peritoneal cavity.

This device is identified by FDA 510(k) number K842139 and is classified under regulation number 876.5955. It is manufactured by Denver Biomedicals, Inc. and is categorized under the product code KPM for use within gastroenterology and urology medical specialties.

Other devices from Denver Biomedicals, Inc.

See all devices from Denver Biomedicals, Inc. →