FDA 510(k)

SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA

K-Number: K923480 · 1992-10-06

Decision Date1992-10-06

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1992-10-06 under 510(k) number K923480. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA?

SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA is a medical device that received FDA 510(k) clearance on 1992-10-06. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K923480.

When did SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA receive FDA 510(k) clearance?

SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA received FDA 510(k) clearance on 1992-10-06, under 510(k) number K923480.

Who is the listed applicant for SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA?

The FDA 510(k) record lists Scimed Life Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA?

The FDA product code for SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA is DQO.

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Other records listing Scimed Life Systems, Inc. as applicant

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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.