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FDA 510(k)

ASPIRA PLEURAL DRAINAGE SYSTEM

K-Number: K071095 · 2007-05-18

ApplicantBard Access Systems, Inc.
Decision Date2007-05-18
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASPIRA PLEURAL DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2007-05-18 under 510(k) number K071095. 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 ASPIRA PLEURAL DRAINAGE SYSTEM?

ASPIRA PLEURAL DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-18. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K071095.

When did ASPIRA PLEURAL DRAINAGE SYSTEM receive FDA 510(k) clearance?

ASPIRA PLEURAL DRAINAGE SYSTEM received FDA 510(k) clearance on 2007-05-18, under 510(k) number K071095.

Who is the listed applicant for ASPIRA PLEURAL DRAINAGE SYSTEM?

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

What is the FDA product code for ASPIRA PLEURAL DRAINAGE SYSTEM?

The FDA product code for ASPIRA PLEURAL DRAINAGE SYSTEM is DWM.

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Other records listing Bard Access Systems, Inc. as applicant

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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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