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FDA 510(k)

CANNULA INTRODUCER

K-Number: K843118 · 1984-11-13

ApplicantCardiovascular Research, Inc.
Decision Date1984-11-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CANNULA INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Research, Inc.. It received FDA 510(k) clearance on 1984-11-13 under 510(k) number K843118. 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 CANNULA INTRODUCER?

CANNULA INTRODUCER is a medical device that received FDA 510(k) clearance on 1984-11-13. The listed applicant is Cardiovascular Research, Inc.. The 510(k) number is K843118.

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

CANNULA INTRODUCER received FDA 510(k) clearance on 1984-11-13, under 510(k) number K843118.

Who is the listed applicant for CANNULA INTRODUCER?

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

What is the FDA product code for CANNULA INTRODUCER?

The FDA product code for CANNULA INTRODUCER is DYB.

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Other records listing Cardiovascular Research, 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.

K800555PARTNER SEVEN DISP. BUBBLE OXYGENATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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