FDA 510(k)

CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE

K-Number: K965023 · 1997-03-04

Decision Date1997-03-04

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE 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 1997-03-04 under 510(k) number K965023. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE?

CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K965023.

When did CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE receive FDA 510(k) clearance?

CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE received FDA 510(k) clearance on 1997-03-04, under 510(k) number K965023.

Who is the listed applicant for CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE?

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 CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE?

The FDA product code for CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE is DQX.

Related Clinical Trials

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Other records listing Scimed Life Systems, Inc. as applicant

K974241SCIMED INFORMER PRESSURE WIRE SYSTEM K981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER K980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES K974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS K974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER K973945LUGE GUIDE WIRE

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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.