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FDA 510(k)

PREMERE DELIVERY SHEATH, MODEL PDS

K-Number: K043084 · 2005-05-02

ApplicantVelocimed, Inc.
Decision Date2005-05-02
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREMERE DELIVERY SHEATH, MODEL PDS is the device name listed in this FDA 510(k) record. The listed applicant is Velocimed, Inc.. It received FDA 510(k) clearance on 2005-05-02 under 510(k) number K043084. 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 PREMERE DELIVERY SHEATH, MODEL PDS?

PREMERE DELIVERY SHEATH, MODEL PDS is a medical device that received FDA 510(k) clearance on 2005-05-02. The listed applicant is Velocimed, Inc.. The 510(k) number is K043084.

When did PREMERE DELIVERY SHEATH, MODEL PDS receive FDA 510(k) clearance?

PREMERE DELIVERY SHEATH, MODEL PDS received FDA 510(k) clearance on 2005-05-02, under 510(k) number K043084.

Who is the listed applicant for PREMERE DELIVERY SHEATH, MODEL PDS?

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

What is the FDA product code for PREMERE DELIVERY SHEATH, MODEL PDS?

The FDA product code for PREMERE DELIVERY SHEATH, MODEL PDS is DYB.

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Other records listing Velocimed, 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.

K052523PROXIS SYSTEMK042117PROXIS SYSTEM, MODEL EPS 101K042910VENTURE WIRE CONTROL CATHETER, MODEL WCCK040922VENTURE WIRE CONTROL CATHETER

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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