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FDA 510(k)

SAFETYNET GUIDEWIRE INTRODUCER

K-Number: K040029 · 2004-04-05

ApplicantInjectimed, Inc.
Decision Date2004-04-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 2004-04-05 under 510(k) number K040029. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFETYNET GUIDEWIRE INTRODUCER?

SAFETYNET GUIDEWIRE INTRODUCER is a medical device that received FDA 510(k) clearance on 2004-04-05. The listed applicant is Injectimed, Inc.. The 510(k) number is K040029.

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

SAFETYNET GUIDEWIRE INTRODUCER received FDA 510(k) clearance on 2004-04-05, under 510(k) number K040029.

Who is the listed applicant for 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 SAFETYNET GUIDEWIRE INTRODUCER?

The FDA product code for SAFETYNET GUIDEWIRE INTRODUCER is DYB.

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.

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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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERK922158PROTECTOR SYRINGE SAFETY CAP SYSTEM

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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