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FDA 510(k)

SELDINGER SAFETY NEEDLE INTRODUCER

K-Number: K032404 · 2003-09-10

ApplicantHdc Corp.
Decision Date2003-09-10
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SELDINGER SAFETY NEEDLE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Hdc Corp.. It received FDA 510(k) clearance on 2003-09-10 under 510(k) number K032404. 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 SELDINGER SAFETY NEEDLE INTRODUCER?

SELDINGER SAFETY NEEDLE INTRODUCER is a medical device that received FDA 510(k) clearance on 2003-09-10. The listed applicant is Hdc Corp.. The 510(k) number is K032404.

When did SELDINGER SAFETY NEEDLE INTRODUCER receive FDA 510(k) clearance?

SELDINGER SAFETY NEEDLE INTRODUCER received FDA 510(k) clearance on 2003-09-10, under 510(k) number K032404.

Who is the listed applicant for SELDINGER SAFETY NEEDLE INTRODUCER?

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

What is the FDA product code for SELDINGER SAFETY NEEDLE INTRODUCER?

The FDA product code for SELDINGER SAFETY NEEDLE INTRODUCER is DYB.

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Other records listing Hdc Corp. 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.

K071875V-CATH POLY PICCK023342NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BGK033853MODIFICATION TO V-CATH POLY PICCK022752PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15K022099SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'SK010425EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)

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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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