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FDA 510(k)

PERCUTANEOUS VENOUS INTRODUCER 10264

K-Number: K965167 · 1997-07-25

ApplicantMedamicus, Inc.
Decision Date1997-07-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS VENOUS INTRODUCER 10264 is the device name listed in this FDA 510(k) record. The listed applicant is Medamicus, Inc.. It received FDA 510(k) clearance on 1997-07-25 under 510(k) number K965167. 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 PERCUTANEOUS VENOUS INTRODUCER 10264?

PERCUTANEOUS VENOUS INTRODUCER 10264 is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is Medamicus, Inc.. The 510(k) number is K965167.

When did PERCUTANEOUS VENOUS INTRODUCER 10264 receive FDA 510(k) clearance?

PERCUTANEOUS VENOUS INTRODUCER 10264 received FDA 510(k) clearance on 1997-07-25, under 510(k) number K965167.

Who is the listed applicant for PERCUTANEOUS VENOUS INTRODUCER 10264?

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 PERCUTANEOUS VENOUS INTRODUCER 10264?

The FDA product code for PERCUTANEOUS VENOUS INTRODUCER 10264 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 RSNK021004VALVED PEELABLE INTRODUCERK020563MEDAMICUS AXIA RSNK013120PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

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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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