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FDA 510(k)

MEDCOMP VASCU-SHEATH II

K-Number: K053092 · 2006-08-01

ApplicantMedcomp
Decision Date2006-08-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDCOMP VASCU-SHEATH II is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp. It received FDA 510(k) clearance on 2006-08-01 under 510(k) number K053092. 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 MEDCOMP VASCU-SHEATH II?

MEDCOMP VASCU-SHEATH II is a medical device that received FDA 510(k) clearance on 2006-08-01. The listed applicant is Medcomp. The 510(k) number is K053092.

When did MEDCOMP VASCU-SHEATH II receive FDA 510(k) clearance?

MEDCOMP VASCU-SHEATH II received FDA 510(k) clearance on 2006-08-01, under 510(k) number K053092.

Who is the listed applicant for MEDCOMP VASCU-SHEATH II?

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

What is the FDA product code for MEDCOMP VASCU-SHEATH II?

The FDA product code for MEDCOMP VASCU-SHEATH II is DYB.

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Other records listing Medcomp 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.

K123292T3K1029662.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICCK091954MICRO-STICK SETK092347PRO-PICC CTK091953PRO-PICCK090394VALVED TEARWAY INTRODUCER

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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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