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)

INSITE STEERABLE GUIDEWIRE

K-Number: K901224 · 1990-06-11

ApplicantLake Region Mfg., Inc.
Decision Date1990-06-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INSITE STEERABLE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 1990-06-11 under 510(k) number K901224. 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 INSITE STEERABLE GUIDEWIRE?

INSITE STEERABLE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1990-06-11. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K901224.

When did INSITE STEERABLE GUIDEWIRE receive FDA 510(k) clearance?

INSITE STEERABLE GUIDEWIRE received FDA 510(k) clearance on 1990-06-11, under 510(k) number K901224.

Who is the listed applicant for INSITE STEERABLE GUIDEWIRE?

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

What is the FDA product code for INSITE STEERABLE GUIDEWIRE?

The FDA product code for INSITE STEERABLE 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 Lake Region Mfg., 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.

K092965TRAILRUNNER GUIDEWIRESK082922FREEWAY AND RAILRUNNER GUIDEWIRESK081708TAXI ENDOSCOPIC GUIDEWIREK080144MANDREL GUIDEWIRES OR M-WIRESK073655PEGASUS STEERABLE (PTCA) GUIDEWIREK060454TITAN GUIDEWIRE

View all 42 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.

↑