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FDA 510(k)

ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM

K-Number: K897126 · 1990-03-13

ApplicantAtrium Medical Corp.
Decision Date1990-03-13
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 1990-03-13 under 510(k) number K897126. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM?

ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-13. The listed applicant is Atrium Medical Corp.. The 510(k) number is K897126.

When did ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM receive FDA 510(k) clearance?

ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM received FDA 510(k) clearance on 1990-03-13, under 510(k) number K897126.

Who is the listed applicant for ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM?

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

What is the FDA product code for ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM?

The FDA product code for ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM is CAC.

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Other records listing Atrium Medical Corp. 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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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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