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FDA 510(k)

ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65

K-Number: K981191 · 1999-04-07

ApplicantIntratherapeutics, Inc.
Decision Date1999-04-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 is the device name listed in this FDA 510(k) record. The listed applicant is Intratherapeutics, Inc.. It received FDA 510(k) clearance on 1999-04-07 under 510(k) number K981191. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65?

ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 is a medical device that received FDA 510(k) clearance on 1999-04-07. The listed applicant is Intratherapeutics, Inc.. The 510(k) number is K981191.

When did ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 receive FDA 510(k) clearance?

ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 received FDA 510(k) clearance on 1999-04-07, under 510(k) number K981191.

Who is the listed applicant for ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65?

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

What is the FDA product code for ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65?

The FDA product code for ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 is DQY.

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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.

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