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FDA 510(k)

OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120

K-Number: K083814 · 2009-01-13

ApplicantCordis Corp., A Johnson & Johnson Co.
Decision Date2009-01-13
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. It received FDA 510(k) clearance on 2009-01-13 under 510(k) number K083814. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120?

OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 is a medical device that received FDA 510(k) clearance on 2009-01-13. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. The 510(k) number is K083814.

When did OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 receive FDA 510(k) clearance?

OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 received FDA 510(k) clearance on 2009-01-13, under 510(k) number K083814.

Who is the listed applicant for OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120?

The FDA 510(k) record lists Cordis Corp., A Johnson & Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120?

The FDA product code for OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 is PDU.

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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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