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FDA 510(k)

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500

K-Number: K022880 · 2002-09-13

ApplicantGuidant Corp.
Decision Date2002-09-13
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2002-09-13 under 510(k) number K022880. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500?

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 is a medical device that received FDA 510(k) clearance on 2002-09-13. The listed applicant is Guidant Corp.. The 510(k) number is K022880.

When did GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 receive FDA 510(k) clearance?

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 received FDA 510(k) clearance on 2002-09-13, under 510(k) number K022880.

Who is the listed applicant for GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500?

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

What is the FDA product code for GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500?

The FDA product code for GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 is DXC.

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Related Devices (Code: DXC)

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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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