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FDA 510(k)

STERILE DRAPE 17X18 W/3 FENESTRATION

K-Number: K801033 · 1980-05-20

ApplicantVeratex Corp.
Decision Date1980-05-20
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DRAPE 17X18 W/3 FENESTRATION is the device name listed in this FDA 510(k) record. The listed applicant is Veratex Corp.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801033. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE DRAPE 17X18 W/3 FENESTRATION?

STERILE DRAPE 17X18 W/3 FENESTRATION is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Veratex Corp.. The 510(k) number is K801033.

When did STERILE DRAPE 17X18 W/3 FENESTRATION receive FDA 510(k) clearance?

STERILE DRAPE 17X18 W/3 FENESTRATION received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801033.

Who is the listed applicant for STERILE DRAPE 17X18 W/3 FENESTRATION?

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

What is the FDA product code for STERILE DRAPE 17X18 W/3 FENESTRATION?

The FDA product code for STERILE DRAPE 17X18 W/3 FENESTRATION is KKX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Veratex Corp. 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.

K830175STERILE COTTON ROLLS #3, 1 1/2K801032STERILE DRAPE 17X18 CODE D-6A

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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