Product Code: KPM FDA class 2 21 CFR 876.5955

Shunt, Peritoneal

Gastroenterology, Urology

This device is a peritoneal shunt used to divert excess peritoneal fluid to another body compartment, most commonly employed in the management of refractory ascites or peritoneal effusions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPM, regulated under 21 CFR 876.5955 within the Gastroenterology and Urology specialty. This device is designated as an implant, as it is surgically placed within the body.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: KPM
Device Class: FDA class 2
Regulation Number: 876.5955
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231096	Automatic Continuous Effusion Shunt (ACES) System ACES System	Aug 18, 2023	Substantially Equivalent	Pleural Dynamics, Inc.
K170405	BD Curve Ascites Shunt	Nov 02, 2017	Unknown	Care Fusion
K012235	DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER	Oct 04, 2001	Substantially Equivalent	Denver Biomedical, Inc.
K011862	DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT	Jul 12, 2001	Substantially Equivalent	Denver Biomedical, Inc.
K011020	DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER	Jun 01, 2001	Substantially Equivalent	Denver Biomedicals, Inc.
K003451	DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T	Jan 02, 2001	Substantially Equivalent	Denver Biomedicals, Inc.
K973129	DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS	Mar 17, 1998	Substantially Equivalent	Denver Biomaterials, Inc.
K962814	DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER	Apr 14, 1997	Substantially Equivalent	Denver Biomaterials, Inc.
K913728	DENVER(R) PERITONEO-SUBCLAVIAN SHUNT	Feb 18, 1994	Substantially Equivalent	Denver Biomedicals, Inc.
K901360	LEVEEN PERITINEO-VENOUS SHUNT	Aug 21, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K894794	AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP	Nov 21, 1989	Substantially Equivalent	Vitaid, Ltd.
K894756	DENVER PERITONEO-VENUS SHUNT	Sep 29, 1989	Substantially Equivalent	Codman & Shurtleff, Inc.
K880570	DENVER PLEURO-PERITONEAL SHUNT	Jun 20, 1988	Substantially Equivalent	Codman & Shurtleff, Inc.
K880401	DENVER PERITONEO-VENOUS SHUNT	May 31, 1988	Substantially Equivalent	Codman & Shurtleff, Inc.
K842139	THE DENVER PLEURAL-PERITONEAL SHUNT	Aug 27, 1984	Substantially Equivalent	Denver Biomedicals, Inc.
K822686	DENVER PERITONEO-VENOUS SHUNT (DP-VS)	Sep 21, 1982	Substantially Equivalent	Denver Biomedicals, Inc.
K811183	DENVER PERITONEO-VENOUS SHUNT	Jul 01, 1981	Substantially Equivalent	Denver Biomedicals, Inc.
K803258	CORDIS HAKIM ASCITES VALVE SYSTEM	Jan 15, 1981	Substantially Equivalent	Cordis Corp.
K770602	VALVE, ASCITES, LAVEEN	Apr 15, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic