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FDA 510(k)

THORACIC CATHETER WITH GUIDE

K-Number: K913542 · 1992-01-21

ApplicantIntl. Medical Devices , Ltd.
Decision Date1992-01-21
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THORACIC CATHETER WITH GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Devices , Ltd.. It received FDA 510(k) clearance on 1992-01-21 under 510(k) number K913542. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THORACIC CATHETER WITH GUIDE?

THORACIC CATHETER WITH GUIDE is a medical device that received FDA 510(k) clearance on 1992-01-21. The listed applicant is Intl. Medical Devices , Ltd.. The 510(k) number is K913542.

When did THORACIC CATHETER WITH GUIDE receive FDA 510(k) clearance?

THORACIC CATHETER WITH GUIDE received FDA 510(k) clearance on 1992-01-21, under 510(k) number K913542.

Who is the listed applicant for THORACIC CATHETER WITH GUIDE?

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

What is the FDA product code for THORACIC CATHETER WITH GUIDE?

The FDA product code for THORACIC CATHETER WITH GUIDE is GBX.

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Other records listing Intl. Medical Devices , Ltd. 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.

K913540PEDIA-THOR THORACOSTOMY KITK913541NEO-THOR THORACOSTOMY KITK913539THORACIC CATHTER STYLETK913543THORACIC CATHETER STYLETK862909RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEMK850398NU-CATH EMERGENCY KIT

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Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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