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FDA 510(k)

SoloPath Re-Collapsible Access System

K-Number: K152498 · 2016-01-05

ApplicantOnset Medical Corporation
Decision Date2016-01-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SoloPath Re-Collapsible Access System is the device name listed in this FDA 510(k) record. The listed applicant is Onset Medical Corporation. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K152498. 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 SoloPath Re-Collapsible Access System?

SoloPath Re-Collapsible Access System is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is Onset Medical Corporation. The 510(k) number is K152498.

When did SoloPath Re-Collapsible Access System receive FDA 510(k) clearance?

SoloPath Re-Collapsible Access System received FDA 510(k) clearance on 2016-01-05, under 510(k) number K152498.

Who is the listed applicant for SoloPath Re-Collapsible Access System?

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

What is the FDA product code for SoloPath Re-Collapsible Access System?

The FDA product code for SoloPath Re-Collapsible Access System is DYB.

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.

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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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