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FDA 510(k)

DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET

K-Number: K002365 · 2000-08-25

ApplicantDatascope Corp.
Decision Date2000-08-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K002365. 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 DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET?

DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Datascope Corp.. The 510(k) number is K002365.

When did DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET receive FDA 510(k) clearance?

DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET received FDA 510(k) clearance on 2000-08-25, under 510(k) number K002365.

Who is the listed applicant for DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET?

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

What is the FDA product code for DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET?

The FDA product code for DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET 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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