510(k) K012235
- Device
- DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- Applicant
- DENVER BIOMEDICAL, INC.
- 510(k) number
- K012235
- Product code
- KPM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-04
- Date received
- 2001-07-17
- Regulation
- 876.5955
- Classification name
- Shunt, Peritoneal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BONNIE B VIVIAN
- Address
- 14998 W. 6th Ave., Bldg. E700 Golden CO US 80401 80401
FDA Registration Numbers#
- 3029300753
- 3006082230
- 1018233
- 1625685
- 1450662
- 3017496797
- 1423507
Source Documents#
Other 510(k) Records For Product Code KPM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. | 2023-08-18 |
| K170405 | BD Curve Ascites Shunt | Care Fusion | 2017-11-02 |
| K011862 | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | Denver Biomedical, Inc. | 2001-07-12 |
| K011020 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedicals, Inc. | 2001-06-01 |
| K003451 | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T | Denver Biomedicals, Inc. | 2001-01-02 |
| K973129 | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS | Denver Biomaterials, Inc. | 1998-03-17 |
| K962814 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomaterials, Inc. | 1997-04-14 |
| K913728 | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | Denver Biomedicals, Inc. | 1994-02-18 |
| K901360 | LEVEEN PERITINEO-VENOUS SHUNT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-08-21 |
| K894794 | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Vitaid, Ltd. | 1989-11-21 |
| K894756 | DENVER PERITONEO-VENUS SHUNT | Codman & Shurtleff, Inc. | 1989-09-29 |
| K880570 | DENVER PLEURO-PERITONEAL SHUNT | Codman & Shurtleff, Inc. | 1988-06-20 |
| K880401 | DENVER PERITONEO-VENOUS SHUNT | Codman & Shurtleff, Inc. | 1988-05-31 |
| K842139 | THE DENVER PLEURAL-PERITONEAL SHUNT | Denver Biomedicals, Inc. | 1984-08-27 |
| K822686 | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | Denver Biomedicals, Inc. | 1982-09-21 |
Legacy Summary#
summary
FDA Review#
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