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FDA 510(k)

BIO-MEDICUS CANNULA INTRODUCER

K-Number: K903410 · 1990-10-31

ApplicantBio Medicus, Inc.
Decision Date1990-10-31
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-MEDICUS CANNULA INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Bio Medicus, Inc.. It received FDA 510(k) clearance on 1990-10-31 under 510(k) number K903410. 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 BIO-MEDICUS CANNULA INTRODUCER?

BIO-MEDICUS CANNULA INTRODUCER is a medical device that received FDA 510(k) clearance on 1990-10-31. The listed applicant is Bio Medicus, Inc.. The 510(k) number is K903410.

When did BIO-MEDICUS CANNULA INTRODUCER receive FDA 510(k) clearance?

BIO-MEDICUS CANNULA INTRODUCER received FDA 510(k) clearance on 1990-10-31, under 510(k) number K903410.

Who is the listed applicant for BIO-MEDICUS CANNULA INTRODUCER?

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

What is the FDA product code for BIO-MEDICUS CANNULA INTRODUCER?

The FDA product code for BIO-MEDICUS CANNULA INTRODUCER is DYB.

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Other records listing Bio Medicus, 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.

K920761URINE CULTUR STABILIZATION TRANSPORT TUBEK901253(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000K901584BIO-MEDICUS BIO CONSOLE MODELS 540 A B CK894980BIO-CAL 370 HEATER/COOLERK884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SETK883956BIO-MEDICUS TUBING CONNECTORS

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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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