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FDA 510(k)

PLURA-GARD CHEST DRAINAGE SYSTEM

K-Number: K844942 · 1985-03-12

ApplicantConsolidated Medical Equipment, Inc.
Decision Date1985-03-12
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLURA-GARD CHEST DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Medical Equipment, Inc.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K844942. 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 PLURA-GARD CHEST DRAINAGE SYSTEM?

PLURA-GARD CHEST DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Consolidated Medical Equipment, Inc.. The 510(k) number is K844942.

When did PLURA-GARD CHEST DRAINAGE SYSTEM receive FDA 510(k) clearance?

PLURA-GARD CHEST DRAINAGE SYSTEM received FDA 510(k) clearance on 1985-03-12, under 510(k) number K844942.

Who is the listed applicant for PLURA-GARD CHEST DRAINAGE SYSTEM?

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

What is the FDA product code for PLURA-GARD CHEST DRAINAGE SYSTEM?

The FDA product code for PLURA-GARD CHEST DRAINAGE SYSTEM is KDQ.

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Other records listing Consolidated Medical Equipment, 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.

K854040I.V. DRESSINGK850130PRN ECG ELECTRODEK850132DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELECK850037CLOSED WOUND DRAINK850311DISPOS. CONDUCTIVE ADHESIVE TENS PADK850131CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS

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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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