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)

PORT-A-TRAC

K-Number: K861554 · 1986-06-19

Decision Date1986-06-19
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PORT-A-TRAC is the device name listed in this FDA 510(k) record. The listed applicant is Port-A-Trac Co.. It received FDA 510(k) clearance on 1986-06-19 under 510(k) number K861554. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT-A-TRAC?

PORT-A-TRAC is a medical device that received FDA 510(k) clearance on 1986-06-19. The listed applicant is Port-A-Trac Co.. The 510(k) number is K861554.

When did PORT-A-TRAC receive FDA 510(k) clearance?

PORT-A-TRAC received FDA 510(k) clearance on 1986-06-19, under 510(k) number K861554.

Who is the listed applicant for PORT-A-TRAC?

The FDA 510(k) record lists Port-A-Trac Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORT-A-TRAC?

The FDA product code for PORT-A-TRAC is JFB.

Related Devices (Code: JFB)

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.

↑