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FDA 510(k)

VALVOKIT

K-Number: K854831 · 1986-03-31

ApplicantNovamed Products, Inc.
Decision Date1986-03-31
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VALVOKIT is the device name listed in this FDA 510(k) record. The listed applicant is Novamed Products, Inc.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K854831. 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 VALVOKIT?

VALVOKIT is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Novamed Products, Inc.. The 510(k) number is K854831.

When did VALVOKIT receive FDA 510(k) clearance?

VALVOKIT received FDA 510(k) clearance on 1986-03-31, under 510(k) number K854831.

Who is the listed applicant for VALVOKIT?

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

What is the FDA product code for VALVOKIT?

The FDA product code for VALVOKIT is DYB.

Related Clinical Trials

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.

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Other records listing Novamed Products, 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.

K821998RESPICORD

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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