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FDA 510(k)

AIRGUIDE STYLETTE

K-Number: K950713 · 1995-05-17

ApplicantPolamedco, Inc.
Decision Date1995-05-17
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRGUIDE STYLETTE is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K950713. 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 AIRGUIDE STYLETTE?

AIRGUIDE STYLETTE is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Polamedco, Inc.. The 510(k) number is K950713.

When did AIRGUIDE STYLETTE receive FDA 510(k) clearance?

AIRGUIDE STYLETTE received FDA 510(k) clearance on 1995-05-17, under 510(k) number K950713.

Who is the listed applicant for AIRGUIDE STYLETTE?

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

What is the FDA product code for AIRGUIDE STYLETTE?

The FDA product code for AIRGUIDE STYLETTE is BSR.

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Other records listing Polamedco, 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.

K983000CRICOTHYROTOMY TUBEK954383SURELOC CIRCUIT CONNECTORK953793INTROSCOPEK933596GASTRIC, CATHETER, IRRIGATION & ASPIRATIONK950380FLEXTITIP STYLETTEK920900POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES

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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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