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)

APPROACH CTO WIRE GUIDE

K-Number: K081337 · 2008-08-08

ApplicantCook Incorporated
Decision Date2008-08-08
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPROACH CTO WIRE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K081337. 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 APPROACH CTO WIRE GUIDE?

APPROACH CTO WIRE GUIDE is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Cook Incorporated. The 510(k) number is K081337.

When did APPROACH CTO WIRE GUIDE receive FDA 510(k) clearance?

APPROACH CTO WIRE GUIDE received FDA 510(k) clearance on 2008-08-08, under 510(k) number K081337.

Who is the listed applicant for APPROACH CTO WIRE GUIDE?

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

What is the FDA product code for APPROACH CTO WIRE GUIDE?

The FDA product code for APPROACH CTO WIRE GUIDE is DQX.

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 Cook Incorporated 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.

K233177Nest VT Vitrification DeviceK222254Gunther Tulip Vena Cava Filter Retrieval SetK223098Bakri Essential Postpartum BalloonK210734Endovascular Dilator and SetsK203670Extra Large Check-Flo IntroducerK191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

View all 158 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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.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.

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.

↑