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FDA 510(k)

MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS

K-Number: K011831 · 2001-06-28

ApplicantDenver Biomedical, Inc.
Decision Date2001-06-28
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomedical, Inc.. It received FDA 510(k) clearance on 2001-06-28 under 510(k) number K011831. 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 MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS?

MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is Denver Biomedical, Inc.. The 510(k) number is K011831.

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

MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS received FDA 510(k) clearance on 2001-06-28, under 510(k) number K011831.

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

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

What is the FDA product code for MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS?

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

Related Clinical Trials

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.

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Other records listing Denver Biomedical, 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.

K051711PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITSK052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000K012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERK011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT

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

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

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