FDA 510(k)

PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR

K-Number: K962856 · 1996-08-28

Decision Date1996-08-28

Product CodeKDQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1996-08-28 under 510(k) number K962856. 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 SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR?

PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR is a medical device that received FDA 510(k) clearance on 1996-08-28. The listed applicant is Deknatel, Inc.. The 510(k) number is K962856.

When did PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR receive FDA 510(k) clearance?

PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR received FDA 510(k) clearance on 1996-08-28, under 510(k) number K962856.

Who is the listed applicant for PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR?

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 SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR?

The FDA product code for PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR is KDQ.

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Other records listing Deknatel, Inc. as applicant

K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM K962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR K964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG K963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)K925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER K930740SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL

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Related Devices (Code: KDQ)

K081718EXPRESS CHEST DRAINAtrium Medical Corp.K062302MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEMMillicore AB K043582OCEAN CHEST DRAINAtrium Medical Corp.K984496ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAINAtrium Medical Corp.K961287ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEMRocket Medical Plc K962168MUCUS SPECIMEN TRAPSage Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.