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FDA 510(k)

DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500

K-Number: K971753 · 1997-06-27

ApplicantDenver Biomaterials, Inc.
Decision Date1997-06-27
Product CodeDWM
Advisory CommitteeCV
DecisionUnknown

Device Summary

DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomaterials, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971753. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500?

DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Denver Biomaterials, Inc.. The 510(k) number is K971753.

When did DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 receive FDA 510(k) clearance?

DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971753.

Who is the listed applicant for DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500?

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

What is the FDA product code for DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500?

The FDA product code for DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 is DWM.

Related Clinical Trials

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Other records listing Denver Biomaterials, 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.

K973129DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITSK962814DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERK960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY

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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