FDA 510(k)

DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER

K-Number: K901391 · 1990-06-26

Decision Date1990-06-26

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K901391. 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 PTCA PERCUTANEOUS CATHETER INTRODUCER?

DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Datascope Corp.. The 510(k) number is K901391.

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

DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER received FDA 510(k) clearance on 1990-06-26, under 510(k) number K901391.

Who is the listed applicant for DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER?

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 PTCA PERCUTANEOUS CATHETER INTRODUCER?

The FDA product code for DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER is 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.