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FDA 510(k)

ATRIUMS PDR THORACIC CATHETER

K-Number: K912645 · 1991-09-13

ApplicantAtrium Medical Corp.
Decision Date1991-09-13
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRIUMS PDR THORACIC CATHETER 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 1991-09-13 under 510(k) number K912645. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRIUMS PDR THORACIC CATHETER?

ATRIUMS PDR THORACIC CATHETER is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Atrium Medical Corp.. The 510(k) number is K912645.

When did ATRIUMS PDR THORACIC CATHETER receive FDA 510(k) clearance?

ATRIUMS PDR THORACIC CATHETER received FDA 510(k) clearance on 1991-09-13, under 510(k) number K912645.

Who is the listed applicant for ATRIUMS PDR THORACIC CATHETER?

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 ATRIUMS PDR THORACIC CATHETER?

The FDA product code for ATRIUMS PDR THORACIC CATHETER is GBS.

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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: GBS)

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.

K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.K872460AN3000 MAHONEY DRAINH.W. Andersen Products, Inc.

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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