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FDA 510(k)

T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES

K-Number: K861025 · 1986-04-28

ApplicantBoehringer Laboratories
Decision Date1986-04-28
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 1986-04-28 under 510(k) number K861025. 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 T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES?

T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES is a medical device that received FDA 510(k) clearance on 1986-04-28. The listed applicant is Boehringer Laboratories. The 510(k) number is K861025.

When did T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES receive FDA 510(k) clearance?

T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES received FDA 510(k) clearance on 1986-04-28, under 510(k) number K861025.

Who is the listed applicant for T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES?

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

What is the FDA product code for T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES?

The FDA product code for T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES is KDQ.

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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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