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FDA 510(k)

PROXIS SYSTEM, MODEL EPS 101

K-Number: K042117 · 2005-01-07

ApplicantVelocimed, Inc.
Decision Date2005-01-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROXIS SYSTEM, MODEL EPS 101 is the device name listed in this FDA 510(k) record. The listed applicant is Velocimed, Inc.. It received FDA 510(k) clearance on 2005-01-07 under 510(k) number K042117. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROXIS SYSTEM, MODEL EPS 101?

PROXIS SYSTEM, MODEL EPS 101 is a medical device that received FDA 510(k) clearance on 2005-01-07. The listed applicant is Velocimed, Inc.. The 510(k) number is K042117.

When did PROXIS SYSTEM, MODEL EPS 101 receive FDA 510(k) clearance?

PROXIS SYSTEM, MODEL EPS 101 received FDA 510(k) clearance on 2005-01-07, under 510(k) number K042117.

Who is the listed applicant for PROXIS SYSTEM, MODEL EPS 101?

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 PROXIS SYSTEM, MODEL EPS 101?

The FDA product code for PROXIS SYSTEM, MODEL EPS 101 is DQY.

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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 SYSTEMK043084PREMERE DELIVERY SHEATH, MODEL PDSK042910VENTURE WIRE CONTROL CATHETER, MODEL WCCK040922VENTURE WIRE CONTROL CATHETER

Related Devices (Code: DQY)

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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Official Source

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