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FDA 510(k)

ATRIUM 2000 CHEST DRAIN

K-Number: K912704 · 1991-08-26

ApplicantAtrium Medical Corp.
Decision Date1991-08-26
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ATRIUM 2000 CHEST DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K912704. The device is classified under product code KDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRIUM 2000 CHEST DRAIN?

ATRIUM 2000 CHEST DRAIN is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Atrium Medical Corp.. The 510(k) number is K912704.

When did ATRIUM 2000 CHEST DRAIN receive FDA 510(k) clearance?

ATRIUM 2000 CHEST DRAIN received FDA 510(k) clearance on 1991-08-26, under 510(k) number K912704.

Who is the listed applicant for ATRIUM 2000 CHEST DRAIN?

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

What is the FDA product code for ATRIUM 2000 CHEST DRAIN?

The FDA product code for ATRIUM 2000 CHEST DRAIN is KDQ.

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Other records listing Atrium Medical Corp. 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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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Related Devices (Code: KDQ)

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.

K081718EXPRESS CHEST DRAINAtrium Medical Corp.K062302MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEMMillicore ABK043582OCEAN CHEST DRAINAtrium Medical Corp.K984496ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAINAtrium Medical Corp.K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRDeknatel, Inc.K961287ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEMRocket Medical Plc

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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