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FDA 510(k)

PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION

K-Number: K892915 · 1989-06-21

ApplicantDeknatel, Inc.
Decision Date1989-06-21
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1989-06-21 under 510(k) number K892915. 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 A-8002--ADULT/PEDIATRIC DUAL COLLECTION?

PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION is a medical device that received FDA 510(k) clearance on 1989-06-21. The listed applicant is Deknatel, Inc.. The 510(k) number is K892915.

When did PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION receive FDA 510(k) clearance?

PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION received FDA 510(k) clearance on 1989-06-21, under 510(k) number K892915.

Who is the listed applicant for PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION?

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 A-8002--ADULT/PEDIATRIC DUAL COLLECTION?

The FDA product code for PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION 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

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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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