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FDA 510(k)

FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER

K-Number: K073664 · 2008-08-08

ApplicantInjectimed, Inc.
Decision Date2008-08-08
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Injectimed, Inc.. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K073664. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER?

FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Injectimed, Inc.. The 510(k) number is K073664.

When did FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER receive FDA 510(k) clearance?

FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER received FDA 510(k) clearance on 2008-08-08, under 510(k) number K073664.

Who is the listed applicant for FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER?

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

What is the FDA product code for FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER?

The FDA product code for FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER is MDM.

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 Injectimed, 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.

K040029SAFETYNET GUIDEWIRE INTRODUCERK922158PROTECTOR SYRINGE SAFETY CAP SYSTEM

Related Devices (Code: MDM)

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.

K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.K010184CHESS HAND SURGERY SYSTEMCanica Design, Inc.

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.

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