DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS— 510(k) K973129
Substantially EquivalentDenver Biomaterials, Inc.
FDA 510(k) clearance K973129 for DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS, Substantially Equivalent on 1998-03-17. Applicant: Denver Biomaterials, Inc.. Device class: 2.
Clearance details
- Applicant
- Denver Biomaterials, Inc.
- Product code
- Code KPM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5955
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Evergreen, CO, US
Recent devices under product code KPM
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- K170405 — BD Curve Ascites Shunt
- K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
- K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
More clearances from Denver Biomaterials, Inc.
view all- K971753 — DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
- K962814 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.