FDA 510(k)

SELECTOR DIAGNOSTIC CATHETER

K-Number: K982077 · 1998-08-11

Decision Date1998-08-11

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SELECTOR DIAGNOSTIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 1998-08-11 under 510(k) number K982077. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTOR DIAGNOSTIC CATHETER?

SELECTOR DIAGNOSTIC CATHETER is a medical device that received FDA 510(k) clearance on 1998-08-11. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K982077.

When did SELECTOR DIAGNOSTIC CATHETER receive FDA 510(k) clearance?

SELECTOR DIAGNOSTIC CATHETER received FDA 510(k) clearance on 1998-08-11, under 510(k) number K982077.

Who is the listed applicant for SELECTOR DIAGNOSTIC CATHETER?

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

What is the FDA product code for SELECTOR DIAGNOSTIC CATHETER?

The FDA product code for SELECTOR DIAGNOSTIC CATHETER is DQO.

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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.