FDA 510(k)

SPECTRA GUIDEWIRE INTRODUCER NEEDLE

K-Number: K082580 · 2008-12-08

Decision Date2008-12-08

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SPECTRA GUIDEWIRE INTRODUCER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices, Inc.. It received FDA 510(k) clearance on 2008-12-08 under 510(k) number K082580. 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 SPECTRA GUIDEWIRE INTRODUCER NEEDLE?

SPECTRA GUIDEWIRE INTRODUCER NEEDLE is a medical device that received FDA 510(k) clearance on 2008-12-08. The listed applicant is Spectra Medical Devices, Inc.. The 510(k) number is K082580.

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

SPECTRA GUIDEWIRE INTRODUCER NEEDLE received FDA 510(k) clearance on 2008-12-08, under 510(k) number K082580.

Who is the listed applicant for SPECTRA GUIDEWIRE INTRODUCER NEEDLE?

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

What is the FDA product code for SPECTRA GUIDEWIRE INTRODUCER NEEDLE?

The FDA product code for SPECTRA GUIDEWIRE INTRODUCER NEEDLE is DYB.

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Other records listing Spectra Medical Devices, Inc. as applicant

K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle K103740SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE K082689STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE K082674SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE K081524SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L

Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture 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, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.