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FDA 510(k)

STYLET TRACHAEL TUBE

K-Number: K905133 · 1991-04-22

ApplicantMedical Devices, Inc.
Decision Date1991-04-22
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STYLET TRACHAEL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K905133. The device is classified under product code BSR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STYLET TRACHAEL TUBE?

STYLET TRACHAEL TUBE is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is Medical Devices, Inc.. The 510(k) number is K905133.

When did STYLET TRACHAEL TUBE receive FDA 510(k) clearance?

STYLET TRACHAEL TUBE received FDA 510(k) clearance on 1991-04-22, under 510(k) number K905133.

Who is the listed applicant for STYLET TRACHAEL TUBE?

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

What is the FDA product code for STYLET TRACHAEL TUBE?

The FDA product code for STYLET TRACHAEL TUBE is BSR.

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Other records listing Medical Devices, 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.

K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602K930084MICRO-ARTHROSCOPEK940012SMARTBRACE ELECTRODEK943126ELECTROFLEXK935132HOME MICROCURRENT HMCK934619FLEXMATE

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Related Devices (Code: BSR)

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.

K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook IncorporatedK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.K943104MOLLOY INTUBATING STYLETTEMolloy Corp.K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., 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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