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FDA 510(k)

THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM

K-Number: K932327 · 1993-07-13

ApplicantDavol, Inc.
Decision Date1993-07-13
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1993-07-13 under 510(k) number K932327. 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 THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM?

THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-07-13. The listed applicant is Davol, Inc.. The 510(k) number is K932327.

When did THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM receive FDA 510(k) clearance?

THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM received FDA 510(k) clearance on 1993-07-13, under 510(k) number K932327.

Who is the listed applicant for THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM?

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

What is the FDA product code for THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM?

The FDA product code for THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM is KDQ.

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Other records listing Davol, 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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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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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