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FDA 510(k)

ASEPT PLEURAL DRAINAGE SYSTEM

K-Number: K093307 · 2009-11-06

ApplicantPfm Medical, Inc.
Decision Date2009-11-06
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASEPT PLEURAL DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2009-11-06 under 510(k) number K093307. 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 ASEPT PLEURAL DRAINAGE SYSTEM?

ASEPT PLEURAL DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-06. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K093307.

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

ASEPT PLEURAL DRAINAGE SYSTEM received FDA 510(k) clearance on 2009-11-06, under 510(k) number K093307.

Who is the listed applicant for ASEPT PLEURAL DRAINAGE SYSTEM?

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

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

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

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Other records listing Pfm Medical, 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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