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FDA 510(k)

PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE

K-Number: K881252 · 1988-06-17

ApplicantDeknatel, Inc.
Decision Date1988-06-17
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1988-06-17 under 510(k) number K881252. 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) A6000 ADULT/PEDIATRIC CHEST DRAINAGE?

PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE is a medical device that received FDA 510(k) clearance on 1988-06-17. The listed applicant is Deknatel, Inc.. The 510(k) number is K881252.

When did PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE receive FDA 510(k) clearance?

PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE received FDA 510(k) clearance on 1988-06-17, under 510(k) number K881252.

Who is the listed applicant for PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE?

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) A6000 ADULT/PEDIATRIC CHEST DRAINAGE?

The FDA product code for PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE 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.

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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.

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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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