Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arrow Quickflash Arterial Catheterization Device

K-Number: K160018 · 2016-06-13

ApplicantArrow International, Inc. (Subsidiary of Teleflex, Inc.)
Decision Date2016-06-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arrow Quickflash Arterial Catheterization Device is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K160018. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arrow Quickflash Arterial Catheterization Device?

Arrow Quickflash Arterial Catheterization Device is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K160018.

When did Arrow Quickflash Arterial Catheterization Device receive FDA 510(k) clearance?

Arrow Quickflash Arterial Catheterization Device received FDA 510(k) clearance on 2016-06-13, under 510(k) number K160018.

Who is the listed applicant for Arrow Quickflash Arterial Catheterization Device?

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

What is the FDA product code for Arrow Quickflash Arterial Catheterization Device?

The FDA product code for Arrow Quickflash Arterial Catheterization Device is DQX.

Other records listing Arrow International, Inc. (Subsidiary of Teleflex, 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.

K180395EZ-IO Intraosseous Vascular Access SystemK163513Arrow Endurance Extended Dwell Peripheral Catheter SystemK161765CG+ Arrow JACCK161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyK153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSK153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

View all 7 devices →

Related Devices (Code: DQX)

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.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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.

↑