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FDA 510(k)

ARROW INTERNATIONAL, INC., SURGICAL DRAPES

K-Number: K071491 · 2007-10-10

ApplicantArrow Intl., Inc.
Decision Date2007-10-10
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARROW INTERNATIONAL, INC., SURGICAL DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 2007-10-10 under 510(k) number K071491. 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 ARROW INTERNATIONAL, INC., SURGICAL DRAPES?

ARROW INTERNATIONAL, INC., SURGICAL DRAPES is a medical device that received FDA 510(k) clearance on 2007-10-10. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K071491.

When did ARROW INTERNATIONAL, INC., SURGICAL DRAPES receive FDA 510(k) clearance?

ARROW INTERNATIONAL, INC., SURGICAL DRAPES received FDA 510(k) clearance on 2007-10-10, under 510(k) number K071491.

Who is the listed applicant for ARROW INTERNATIONAL, INC., SURGICAL DRAPES?

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

What is the FDA product code for ARROW INTERNATIONAL, INC., SURGICAL DRAPES?

The FDA product code for ARROW INTERNATIONAL, INC., SURGICAL DRAPES is KKX.

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Other records listing Arrow Intl., 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.

K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520K071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTK071111NON-ABSORBABLE SILK SUTUREK060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIESK042126PICC

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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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