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FDA 510(k)

TRAKEFIT TRACHEOSTOMY TUBE HOLDER

K-Number: K872277 · 1987-07-21

ApplicantAckrad Laboratories
Decision Date1987-07-21
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRAKEFIT TRACHEOSTOMY TUBE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872277. The device is classified under product code CBH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAKEFIT TRACHEOSTOMY TUBE HOLDER?

TRAKEFIT TRACHEOSTOMY TUBE HOLDER is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Ackrad Laboratories. The 510(k) number is K872277.

When did TRAKEFIT TRACHEOSTOMY TUBE HOLDER receive FDA 510(k) clearance?

TRAKEFIT TRACHEOSTOMY TUBE HOLDER received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872277.

Who is the listed applicant for TRAKEFIT TRACHEOSTOMY TUBE HOLDER?

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 TRAKEFIT TRACHEOSTOMY TUBE HOLDER?

The FDA product code for TRAKEFIT TRACHEOSTOMY TUBE HOLDER is CBH.

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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: CBH)

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.

K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.K942529HCI TUBE STABILIZERHealth Care Contracts, Inc.K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSDale Medical Products, Inc.K950930TRACHE-TITEThe Varner Group, Inc.K950318FLEX BLUEKing Systems Corp.K942395ENDOTRACHEAL TUBE HOLDERS.T.I. Medical Products Corp.

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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