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FDA 510(k)

THE DENVER PLEURAL-PERITONEAL SHUNT

K-Number: K842139 · 1984-08-27

ApplicantDenver Biomedicals, Inc.
Decision Date1984-08-27
Product CodeKPM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE DENVER PLEURAL-PERITONEAL SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomedicals, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K842139. The device is classified under product code KPM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DENVER PLEURAL-PERITONEAL SHUNT?

THE DENVER PLEURAL-PERITONEAL SHUNT is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Denver Biomedicals, Inc.. The 510(k) number is K842139.

When did THE DENVER PLEURAL-PERITONEAL SHUNT receive FDA 510(k) clearance?

THE DENVER PLEURAL-PERITONEAL SHUNT received FDA 510(k) clearance on 1984-08-27, under 510(k) number K842139.

Who is the listed applicant for THE DENVER PLEURAL-PERITONEAL SHUNT?

The FDA 510(k) record lists Denver Biomedicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE DENVER PLEURAL-PERITONEAL SHUNT?

The FDA product code for THE DENVER PLEURAL-PERITONEAL SHUNT is KPM.

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Other records listing Denver Biomedicals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINEK011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERK010642PLEURX PLEURAL CATHETER AND DRAINAGE KITSK003451DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES TK943968TUNNELERK913728DENVER(R) PERITONEO-SUBCLAVIAN SHUNT

View all 10 devices →

Related Devices (Code: KPM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc.K170405BD Curve Ascites ShuntCare FusionK012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomedical, Inc.K011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNTDenver Biomedical, Inc.K011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomedicals, Inc.K003451DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES TDenver Biomedicals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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