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FDA 510(k)

THORACIC CATHTER STYLET

K-Number: K913539 · 1992-01-21

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

Device Summary

THORACIC CATHTER STYLET 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 K913539. 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 CATHTER STYLET?

THORACIC CATHTER STYLET 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 K913539.

When did THORACIC CATHTER STYLET receive FDA 510(k) clearance?

THORACIC CATHTER STYLET received FDA 510(k) clearance on 1992-01-21, under 510(k) number K913539.

Who is the listed applicant for THORACIC CATHTER STYLET?

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 CATHTER STYLET?

The FDA product code for THORACIC CATHTER STYLET 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 KITK913542THORACIC CATHETER WITH GUIDEK913543THORACIC CATHETER STYLETK862909RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEMK850398NU-CATH EMERGENCY KIT

View all 12 devices →

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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