FDA 510(k)

USCI ILLUMEN-8 8F PTCA GUIDING CATHETER

K-Number: K910154 · 1991-04-09

Decision Date1991-04-09

Product CodeDOY

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

USCI ILLUMEN-8 8F PTCA GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1991-04-09 under 510(k) number K910154. The device is classified under product code DOY. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USCI ILLUMEN-8 8F PTCA GUIDING CATHETER?

USCI ILLUMEN-8 8F PTCA GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1991-04-09. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K910154.

When did USCI ILLUMEN-8 8F PTCA GUIDING CATHETER receive FDA 510(k) clearance?

USCI ILLUMEN-8 8F PTCA GUIDING CATHETER received FDA 510(k) clearance on 1991-04-09, under 510(k) number K910154.

Who is the listed applicant for USCI ILLUMEN-8 8F PTCA GUIDING CATHETER?

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

What is the FDA product code for USCI ILLUMEN-8 8F PTCA GUIDING CATHETER?

The FDA product code for USCI ILLUMEN-8 8F PTCA GUIDING CATHETER is DOY.

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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.