FDA 510(k)

EVAC-TUBE

K-Number: K894032 · 1989-08-31

Decision Date1989-08-31

Product CodeCAO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EVAC-TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Sharn, Inc.. It received FDA 510(k) clearance on 1989-08-31 under 510(k) number K894032. The device is classified under product code CAO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVAC-TUBE?

EVAC-TUBE is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Sharn, Inc.. The 510(k) number is K894032.

When did EVAC-TUBE receive FDA 510(k) clearance?

EVAC-TUBE received FDA 510(k) clearance on 1989-08-31, under 510(k) number K894032.

Who is the listed applicant for EVAC-TUBE?

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

What is the FDA product code for EVAC-TUBE?

The FDA product code for EVAC-TUBE is CAO.

Other records listing Sharn, 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.

K070596TOPICAL APPLICATOR K932305VILA-COOKE(TM) ANESTHESIA PILLOW K860558ESOPHAGEAL STETHOSCOPE

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K971348FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEMGreen Field Medical Sourcing, Inc.K875226ESOPHAGEAL OBTURATOR/TRACHEAL TUBESheridan Catheter Corp.K864200VETA/VENTED ESOPHAGEAL TUBE AIRWAYCranco Co.K863172RESPIRONICS PTL REVIVEEASYRespironics, Inc.K761195ESOPHAGEAL OBTURATION AIRWAYMckesson Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.