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FDA 510(k)

AXIOM TROCAR THORACIC CATHETER

K-Number: K863247 · 1986-08-29

ApplicantAxiom Medical, Inc.
Decision Date1986-08-29
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AXIOM TROCAR THORACIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1986-08-29 under 510(k) number K863247. 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 AXIOM TROCAR THORACIC CATHETER?

AXIOM TROCAR THORACIC CATHETER is a medical device that received FDA 510(k) clearance on 1986-08-29. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K863247.

When did AXIOM TROCAR THORACIC CATHETER receive FDA 510(k) clearance?

AXIOM TROCAR THORACIC CATHETER received FDA 510(k) clearance on 1986-08-29, under 510(k) number K863247.

Who is the listed applicant for AXIOM TROCAR THORACIC CATHETER?

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

What is the FDA product code for AXIOM TROCAR THORACIC CATHETER?

The FDA product code for AXIOM TROCAR THORACIC CATHETER is GBS.

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Other records listing Axiom Medical, 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.

K993592AXIOM MULTIPURPOSE WOUND DRAINK971851INTERPLEURAL ANESTHESIA CATHETERK965146FLAT CLOSED WOUND DRAIN WITH TROCARK934895GLASSMAN SILICONE CATHETERK922760ATRAUM WOUND DRESSING--MODIFICATIONK905422PVC ROUND WOUND DRAINS

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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.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.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.

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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