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)

ARCHER SUPER STIFF GUIDEWIRES

K-Number: K101339 · 2010-08-31

ApplicantMedtronic, Inc.
Decision Date2010-08-31
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARCHER SUPER STIFF GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K101339. 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 ARCHER SUPER STIFF GUIDEWIRES?

ARCHER SUPER STIFF GUIDEWIRES is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Medtronic, Inc.. The 510(k) number is K101339.

When did ARCHER SUPER STIFF GUIDEWIRES receive FDA 510(k) clearance?

ARCHER SUPER STIFF GUIDEWIRES received FDA 510(k) clearance on 2010-08-31, under 510(k) number K101339.

Who is the listed applicant for ARCHER SUPER STIFF GUIDEWIRES?

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

What is the FDA product code for ARCHER SUPER STIFF GUIDEWIRES?

The FDA product code for ARCHER SUPER STIFF GUIDEWIRES 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 Medtronic, 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.

K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemK262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)K262005Affera Integrated Mapping SystemK261335VitalFlow Set with Balance™ BiosurfaceK261866Concerto Versa™ Detachable CoilK260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

View all 182 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.

↑