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FDA 510(k)

N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE

K-Number: K865108 · 1987-02-10

ApplicantAckrad Laboratories
Decision Date1987-02-10
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1987-02-10 under 510(k) number K865108. 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 N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE?

N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Ackrad Laboratories. The 510(k) number is K865108.

When did N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE receive FDA 510(k) clearance?

N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE received FDA 510(k) clearance on 1987-02-10, under 510(k) number K865108.

Who is the listed applicant for N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE?

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

What is the FDA product code for N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE?

The FDA product code for N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE is BSR.

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Other records listing Ackrad Laboratories 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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

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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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