FDA 510(k)

SPIRAL-FLEX

K-Number: K860105 · 1986-03-04

Decision Date1986-03-04

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPIRAL-FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Sheridan Catheter Corp.. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K860105. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRAL-FLEX?

SPIRAL-FLEX is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Sheridan Catheter Corp.. The 510(k) number is K860105.

When did SPIRAL-FLEX receive FDA 510(k) clearance?

SPIRAL-FLEX received FDA 510(k) clearance on 1986-03-04, under 510(k) number K860105.

Who is the listed applicant for SPIRAL-FLEX?

The FDA 510(k) record lists Sheridan Catheter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRAL-FLEX?

The FDA product code for SPIRAL-FLEX is BTR.

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Related Devices (Code: BTR)

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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.