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FDA 510(k)

VALVED PEELABLE INTRODUCER

K-Number: K021004 · 2002-06-06

ApplicantMedamicus, Inc.
Decision Date2002-06-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VALVED PEELABLE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Medamicus, Inc.. It received FDA 510(k) clearance on 2002-06-06 under 510(k) number K021004. 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 VALVED PEELABLE INTRODUCER?

VALVED PEELABLE INTRODUCER is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is Medamicus, Inc.. The 510(k) number is K021004.

When did VALVED PEELABLE INTRODUCER receive FDA 510(k) clearance?

VALVED PEELABLE INTRODUCER received FDA 510(k) clearance on 2002-06-06, under 510(k) number K021004.

Who is the listed applicant for VALVED PEELABLE INTRODUCER?

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

What is the FDA product code for VALVED PEELABLE INTRODUCER?

The FDA product code for VALVED PEELABLE INTRODUCER is DYB.

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Other records listing Medamicus, 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.

K040150MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCERK030905MEDAMICUS FLOWGUARD PEELABLE INTRODUCERK022689MODIFICATION TO MEDAMICUS AXIA RSNK020563MEDAMICUS AXIA RSNK013120PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18K011085GUIDEWIRE INTRODUCER SAFETY NEEDLE

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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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