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FDA 510(k)

SOS BLOODLESS NEEDLE

K-Number: K914330 · 1991-12-20

ApplicantE-Z-Em, Inc.
Decision Date1991-12-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOS BLOODLESS NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1991-12-20 under 510(k) number K914330. 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 SOS BLOODLESS NEEDLE?

SOS BLOODLESS NEEDLE is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K914330.

When did SOS BLOODLESS NEEDLE receive FDA 510(k) clearance?

SOS BLOODLESS NEEDLE received FDA 510(k) clearance on 1991-12-20, under 510(k) number K914330.

Who is the listed applicant for SOS BLOODLESS NEEDLE?

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

What is the FDA product code for SOS BLOODLESS NEEDLE?

The FDA product code for SOS BLOODLESS NEEDLE is DYB.

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Other records listing E-Z-Em, 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.

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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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