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FDA 510(k)

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX

K-Number: K001367 · 2000-05-31

ApplicantSt. Jude Medical, Inc.
Decision Date2000-05-31
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2000-05-31 under 510(k) number K001367. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX?

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX is a medical device that received FDA 510(k) clearance on 2000-05-31. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K001367.

When did FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX receive FDA 510(k) clearance?

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX received FDA 510(k) clearance on 2000-05-31, under 510(k) number K001367.

Who is the listed applicant for FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX?

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

What is the FDA product code for FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX?

The FDA product code for FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX is DYB.

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Related Devices (Code: DYB)

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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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