FDA 510(k)

SPYGLASS 4 FR ANGIOGRAPHICY CATHETER

K-Number: K020890 · 2002-04-17

Decision Date2002-04-17

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SPYGLASS 4 FR ANGIOGRAPHICY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2002-04-17 under 510(k) number K020890. 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 SPYGLASS 4 FR ANGIOGRAPHICY CATHETER?

SPYGLASS 4 FR ANGIOGRAPHICY CATHETER is a medical device that received FDA 510(k) clearance on 2002-04-17. The listed applicant is St Jude Medical. The 510(k) number is K020890.

When did SPYGLASS 4 FR ANGIOGRAPHICY CATHETER receive FDA 510(k) clearance?

SPYGLASS 4 FR ANGIOGRAPHICY CATHETER received FDA 510(k) clearance on 2002-04-17, under 510(k) number K020890.

Who is the listed applicant for SPYGLASS 4 FR ANGIOGRAPHICY CATHETER?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPYGLASS 4 FR ANGIOGRAPHICY CATHETER?

The FDA product code for SPYGLASS 4 FR ANGIOGRAPHICY 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.