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FDA 510(k)

Standard Catheter Set

K-Number: K171631 · 2018-02-09

Decision Date2018-02-09
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Standard Catheter Set is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K171631. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Standard Catheter Set?

Standard Catheter Set is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K171631.

When did Standard Catheter Set receive FDA 510(k) clearance?

Standard Catheter Set received FDA 510(k) clearance on 2018-02-09, under 510(k) number K171631.

Who is the listed applicant for Standard Catheter Set?

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

What is the FDA product code for Standard Catheter Set?

The FDA product code for Standard Catheter Set is JAQ.

Other records listing Varian Medical Systems, 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.

View all 96 devices →

Related Devices (Code: JAQ)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.