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FDA 510(k)

OWENS CATHETER

K-Number: K896520 · 1991-03-25

ApplicantBoston Scientific Corp
Decision Date1991-03-25
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OWENS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1991-03-25 under 510(k) number K896520. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OWENS CATHETER?

OWENS CATHETER is a medical device that received FDA 510(k) clearance on 1991-03-25. The listed applicant is Boston Scientific Corp. The 510(k) number is K896520.

When did OWENS CATHETER receive FDA 510(k) clearance?

OWENS CATHETER received FDA 510(k) clearance on 1991-03-25, under 510(k) number K896520.

Who is the listed applicant for OWENS CATHETER?

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

What is the FDA product code for OWENS CATHETER?

The FDA product code for OWENS CATHETER is LIT.

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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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