Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RADKOR, CST-18

K-Number: K882563 · 1988-07-08

ApplicantRadkor, Inc.
Decision Date1988-07-08
Product CodeIYB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADKOR, CST-18 is the device name listed in this FDA 510(k) record. The listed applicant is Radkor, Inc.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K882563. The device is classified under product code IYB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADKOR, CST-18?

RADKOR, CST-18 is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Radkor, Inc.. The 510(k) number is K882563.

When did RADKOR, CST-18 receive FDA 510(k) clearance?

RADKOR, CST-18 received FDA 510(k) clearance on 1988-07-08, under 510(k) number K882563.

Who is the listed applicant for RADKOR, CST-18?

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

What is the FDA product code for RADKOR, CST-18?

The FDA product code for RADKOR, CST-18 is IYB.

Related Clinical Trials

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.

Other records listing Radkor, 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 10 devices →

Related Devices (Code: IYB)

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

View on FDA Database →

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

↑