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FDA 510(k)

IVT 0.014 PTFE-COATED TRACKWIRE

K-Number: K971688 · 1997-12-11

ApplicantBoston Scientific /International Technologies
Decision Date1997-12-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IVT 0.014 PTFE-COATED TRACKWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific /International Technologies. It received FDA 510(k) clearance on 1997-12-11 under 510(k) number K971688. 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 IVT 0.014 PTFE-COATED TRACKWIRE?

IVT 0.014 PTFE-COATED TRACKWIRE is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is Boston Scientific /International Technologies. The 510(k) number is K971688.

When did IVT 0.014 PTFE-COATED TRACKWIRE receive FDA 510(k) clearance?

IVT 0.014 PTFE-COATED TRACKWIRE received FDA 510(k) clearance on 1997-12-11, under 510(k) number K971688.

Who is the listed applicant for IVT 0.014 PTFE-COATED TRACKWIRE?

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

What is the FDA product code for IVT 0.014 PTFE-COATED TRACKWIRE?

The FDA product code for IVT 0.014 PTFE-COATED TRACKWIRE 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 /International Technologies 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.

K96366311F GUIDING CATHETERK954552RAILWIREK954622IVT 0.014 TRACK OR IVT 0.014 ACCUTRACKK930808PROTECTOR INTRODUCER SHEATH

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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