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FDA 510(k)

ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET

K-Number: K013241 · 2002-02-21

ApplicantCook, Inc.
Decision Date2002-02-21
Product CodeBWC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2002-02-21 under 510(k) number K013241. The device is classified under product code BWC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET?

ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET is a medical device that received FDA 510(k) clearance on 2002-02-21. The listed applicant is Cook, Inc.. The 510(k) number is K013241.

When did ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET receive FDA 510(k) clearance?

ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET received FDA 510(k) clearance on 2002-02-21, under 510(k) number K013241.

Who is the listed applicant for ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET?

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

What is the FDA product code for ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET?

The FDA product code for ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET is BWC.

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Other records listing Cook, 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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Related Devices (Code: BWC)

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.

K200190ScalpelCricVBM Medizintechnik GmbHK160200Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter SetCook IncorporatedK153761Emergency Transtracheal Airway CatheterCook IncorporatedK130405RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SETTeleflex MedicalK050166PORTEX EMERGENCY CRICOTHYROIDOTOMY KITSmiths MedicalK013252PATIL EMERGENCY CRICOTHYROTOMY CATHETER SETCook, 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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