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FDA 510(k)

INTRODUCER, PERCUTANEOUS

K-Number: K900658 · 1990-08-23

ApplicantNovoste Puerto Rico, Inc.
Decision Date1990-08-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRODUCER, PERCUTANEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Novoste Puerto Rico, Inc.. It received FDA 510(k) clearance on 1990-08-23 under 510(k) number K900658. 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 INTRODUCER, PERCUTANEOUS?

INTRODUCER, PERCUTANEOUS is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Novoste Puerto Rico, Inc.. The 510(k) number is K900658.

When did INTRODUCER, PERCUTANEOUS receive FDA 510(k) clearance?

INTRODUCER, PERCUTANEOUS received FDA 510(k) clearance on 1990-08-23, under 510(k) number K900658.

Who is the listed applicant for INTRODUCER, PERCUTANEOUS?

The FDA 510(k) record lists Novoste Puerto Rico, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRODUCER, PERCUTANEOUS?

The FDA product code for INTRODUCER, PERCUTANEOUS is DYB.

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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