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FDA 510(k)

THORACIC CATHETER STYLET

K-Number: K913543 · 1991-10-04

ApplicantIntl. Medical Devices , Ltd.
Decision Date1991-10-04
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THORACIC CATHETER 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 1991-10-04 under 510(k) number K913543. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THORACIC CATHETER STYLET?

THORACIC CATHETER STYLET is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Intl. Medical Devices , Ltd.. The 510(k) number is K913543.

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

THORACIC CATHETER STYLET received FDA 510(k) clearance on 1991-10-04, under 510(k) number K913543.

Who is the listed applicant for THORACIC CATHETER 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 CATHETER STYLET?

The FDA product code for THORACIC CATHETER STYLET is DRB.

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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 GUIDEK913539THORACIC CATHTER STYLETK862909RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEMK850398NU-CATH EMERGENCY KIT

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Related Devices (Code: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook IncorporatedK090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude MedicalK080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi

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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