FDA 510(k)

SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH

K-Number: K935654 · 1994-02-22

Decision Date1994-02-22

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH 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 1994-02-22 under 510(k) number K935654. 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 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH?

SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K935654.

When did SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH receive FDA 510(k) clearance?

SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH received FDA 510(k) clearance on 1994-02-22, under 510(k) number K935654.

Who is the listed applicant for SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH?

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 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH?

The FDA product code for SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH is DQO.

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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.