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FDA 510(k)

PLEUR-EVAC CHEST DRAINAGE SYSTEMS

K-Number: K905768 · 1991-02-11

ApplicantDeknatel, Inc.
Decision Date1991-02-11
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC CHEST DRAINAGE SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905768. 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 PLEUR-EVAC CHEST DRAINAGE SYSTEMS?

PLEUR-EVAC CHEST DRAINAGE SYSTEMS is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Deknatel, Inc.. The 510(k) number is K905768.

When did PLEUR-EVAC CHEST DRAINAGE SYSTEMS receive FDA 510(k) clearance?

PLEUR-EVAC CHEST DRAINAGE SYSTEMS received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905768.

Who is the listed applicant for PLEUR-EVAC CHEST DRAINAGE SYSTEMS?

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

What is the FDA product code for PLEUR-EVAC CHEST DRAINAGE SYSTEMS?

The FDA product code for PLEUR-EVAC CHEST DRAINAGE SYSTEMS is KDQ.

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Other records listing Deknatel, 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.

K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATORK964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGK963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRK925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER

View all 37 devices →

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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