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)

KINETIX GUIDEWIRE, PLUS GUIDEWIRE

K-Number: K081021 · 2008-08-08

ApplicantBoston Scientific Corp
Decision Date2008-08-08
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KINETIX GUIDEWIRE, PLUS GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K081021. 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 KINETIX GUIDEWIRE, PLUS GUIDEWIRE?

KINETIX GUIDEWIRE, PLUS GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Boston Scientific Corp. The 510(k) number is K081021.

When did KINETIX GUIDEWIRE, PLUS GUIDEWIRE receive FDA 510(k) clearance?

KINETIX GUIDEWIRE, PLUS GUIDEWIRE received FDA 510(k) clearance on 2008-08-08, under 510(k) number K081021.

Who is the listed applicant for KINETIX GUIDEWIRE, PLUS GUIDEWIRE?

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

What is the FDA product code for KINETIX GUIDEWIRE, PLUS GUIDEWIRE?

The FDA product code for KINETIX GUIDEWIRE, PLUS GUIDEWIRE 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 Boston Scientific 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.

K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSK133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEM

View all 414 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.

↑