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FDA 510(k)

PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS

K-Number: K924337 · 1993-07-28

ApplicantDeknatel, Inc.
Decision Date1993-07-28
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1993-07-28 under 510(k) number K924337. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS?

PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS is a medical device that received FDA 510(k) clearance on 1993-07-28. The listed applicant is Deknatel, Inc.. The 510(k) number is K924337.

When did PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS receive FDA 510(k) clearance?

PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS received FDA 510(k) clearance on 1993-07-28, under 510(k) number K924337.

Who is the listed applicant for PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS?

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(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS?

The FDA product code for PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS is GCX.

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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: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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