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FDA 510(k)

PLEURX PLEURAL CATHETER AND DRAINAGE KITS

K-Number: K010642 · 2001-03-20

ApplicantDenver Biomedicals, Inc.
Decision Date2001-03-20
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PLEURX PLEURAL CATHETER AND DRAINAGE KITS 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 2001-03-20 under 510(k) number K010642. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEURX PLEURAL CATHETER AND DRAINAGE KITS?

PLEURX PLEURAL CATHETER AND DRAINAGE KITS is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Denver Biomedicals, Inc.. The 510(k) number is K010642.

When did PLEURX PLEURAL CATHETER AND DRAINAGE KITS receive FDA 510(k) clearance?

PLEURX PLEURAL CATHETER AND DRAINAGE KITS received FDA 510(k) clearance on 2001-03-20, under 510(k) number K010642.

Who is the listed applicant for PLEURX PLEURAL CATHETER AND DRAINAGE KITS?

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 PLEURX PLEURAL CATHETER AND DRAINAGE KITS?

The FDA product code for PLEURX PLEURAL CATHETER AND DRAINAGE KITS is DWM.

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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 CHAMBERK003451DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES TK943968TUNNELERK913728DENVER(R) PERITONEO-SUBCLAVIAN SHUNTK842139THE DENVER PLEURAL-PERITONEAL SHUNT

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Related Devices (Code: DWM)

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.

K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.K210509Rocket Platinum Cured CathterRocket Medical PlcK201404Passio Pump Drainage SystemBearpac MedicalK190292Passio Pump Drainage SystemBearpac MedicalK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical PlcK160450Pleurx Pleural Catheter SystemCare Fusion

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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